Brachial Plexus Block Versus General Anesthesia for Upper-Extremity Orthopedic Surgery: Effect on Preoperative Anxiety and Recovery Outcomes – A Randomized Controlled Trial

Brachial Plexus Block Versus General Anesthesia for Upper-Extremity Orthopedic Surgery: Effect on Preoperative Anxiety and Recovery Outcomes – A Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Brachial Plexus Block Versus General Anesthesia for Upper-Extremity Orthopedic Surgery: Effect on Preoperative Anxiety and Recovery Outcomes – A Randomized Controlled Trial Dilek Ucak, Hatice Simsek Ulku, Osman Ciloglu, Cagla Bali This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8465510/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Preoperative anxiety is common in surgical patients and associated with adverse perioperative outcomes. While ultrasound-guided brachial plexus block (BPB) provides effective analgesia for upper-extremity surgery, its isolated effect on preoperative anxiety compared with general anesthesia (GA) remains underexplored. This randomized controlled trial compared BPB with GA for their effects on preoperative anxiety and postoperative recovery in adults undergoing elective upper-extremity orthopedic surgery. Methods: We conducted a prospective, randomized, parallel-group superiority trial at a tertiary academic hospital. Adults aged 18–65 years with ASA physical status I–II undergoing elective upper-extremity orthopedic procedures were randomized 1:1 to ultrasound-guided infraclavicular BPB or GA. All participants received standardized preoperative education and harmonized perioperative care. Primary endpoint was preoperative anxiety immediately prior to operating room entry measured using State-Trait Anxiety Inventory-State (STAI-S). Secondary endpoints included pain scores, opioid consumption, postoperative nausea and vomiting (PONV), post-anesthesia care unit (PACU) length of stay, quality of recovery-15 (QoR-15), and patient satisfaction. Results: 120 patients were randomized (60 per group) with 0% loss to follow-up. BPB reduced preoperative anxiety compared with GA (STAI-S: adjusted mean difference −3.03, 95% CI: −6.04 to −0.02, p=0.048). BPB also demonstrated superior outcomes in early pain reduction (adjusted MD −1.43, p<0.001), opioid consumption (mean ratio 0.52, p<0.001), PONV incidence (adjusted OR 0.36, p=0.025), PACU length of stay (median difference −18.3 min, p<0.001), QoR-15 scores (adjusted MD 9.92, p<0.001), and patient satisfaction (adjusted MD 0.37, p=0.004). Five patients (8%) in the BPB arm required conversion to GA. No serious adverse events occurred. Conclusions: Within a standardized perioperative pathway, brachial plexus block was associated with a statistically significant but clinically modest reduction in preoperative anxiety, accompanied by robust multidomain recovery advantages over general anesthesia. The clinical significance of the isolated anxiety reduction remains uncertain; however, the constellation of benefits across pain, opioid consumption, PONV, and quality of recovery supports an overall favorable treatment effect for regional anesthesia in upper-extremity orthopedic surgery. Trial Registration: ClinicalTrials.gov NCT07352839. Retrospectively registered on January 13, 2026. Brachial plexus block General anesthesia Preoperative anxiety Regional anesthesia Upper extremity surgery Perioperative outcomes Quality of recovery Randomized controlled trial Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 INTRODUCTION Upper-extremity orthopedic procedures constitute high-volume ambulatory surgery worldwide (1,2). General anesthesia (GA) provides reliable immobility but associates with postoperative nausea/vomiting (PONV) (1,2), opioid requirements, and prolonged phase I recovery. Ultrasound-guided brachial plexus block (BPB) delivers dense, limb-specific analgesia (3,4), potentially mitigating these deficits while enabling earlier functional recovery (3,4). Preoperative anxiety, prevalent in 20-40% of patients, independently predicts worse acute pain, opioid consumption, and convalescence (5). Validated instruments including State-Trait Anxiety Inventory-State (STAI-S) (6,7) and Amsterdam Preoperative Anxiety and Information Scale (APAIS) (8) facilitate precise phenotyping. While education, counseling, and premedication reduce anxiety (5,9), the isolated effect of anesthetic technique (BPB vs GA) remains underexplored, with existing trials heterogeneously controlling co-interventions (3,4,9). Prior BPB-GA comparisons emphasize analgesia, PONV reduction, and length-of-stay benefits (3,4) but inadequately standardize education/sedation or prioritize anxiety as primary endpoint (9,10). Variable anxiety measurement timing (clinic vs holding vs pre-induction) and technique-specific informational differences further confound interpretation. This randomized controlled trial addresses these gaps (11,12). Brachial plexus block (BPB) was compared with general anesthesia (GA) in adults undergoing elective upper-extremity orthopedic surgery using prespecified standardized preoperative information package and harmonized sedation protocols to minimize performance bias (3,4,9). Primary objective: BPB reduces preoperative anxiety measured immediately prior to operating room entry using STAI-S versus GA (6,7,8). Secondary objectives: postoperative pain trajectories, 24-hour opioid consumption, PONV incidence, post-anesthesia care unit (PACU) length of stay, quality of recovery-15 (QoR-15) (13), patient satisfaction, anesthesia-related adverse events. Exploratory aim: anxiety change mediates clinical outcome differences. MATERIALS AND METHODS A prospective, randomized, parallel-group, superiority trial comparing ultrasound-guided brachial plexus block (BPB) with general anesthesia (GA) for adults undergoing elective upper-extremity orthopedic surgery was conducted (11,12). The study took place in the preoperative assessment clinic, operating theatres, and post-anesthesia care unit (PACU) of a tertiary academic hospital. The protocol was finalized before patient enrollment and reported in accordance with CONSORT and SPIRIT statements (11,12). Trial Registration This trial was retrospectively registered at ClinicalTrials.gov (NCT07352839) on January 13, 2026. CONSORT Compliance This trial was conducted and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. A completed CONSORT checklist is provided as Additional File 1. Validated Instruments All questionnaires used in this study were previously published and validated instruments: 1. State-Trait Anxiety Inventory-State (STAI-S): A widely validated 20-item questionnaire assessing state anxiety [6]. 2. Quality of Recovery-15 (QoR-15): A validated 15-item patient-reported outcome measure for postoperative recovery quality [13]. 3. Visual Analog Scale (VAS): A standard validated pain assessment tool widely used in clinical practice. Participants Consecutive patients scheduled for elective upper-extremity orthopedic procedures (elbow, forearm, wrist, or hand) were screened in the preoperative clinic. Inclusion criteria were age 18–65 years and American Society of Anesthesiologists (ASA) physical status I–II. Exclusion criteria were: contraindications to regional anesthesia (coagulopathy, local infection at injection site), allergy to study medications, pregnancy or lactation, chronic opioid therapy (>30 mg oral morphine equivalents/day for >3 months), major psychiatric or cognitive disorders interfering with questionnaire completion, initiation/discontinuation of psychoactive medications within 4 weeks, morbid obesity (body mass index >40 kg⋅m⁻²), severe pulmonary disease increasing pneumothorax risk (14), emergent surgery, and inability to provide informed consent. Written informed consent was obtained by trained investigators. A total of 120 patients meeting eligibility criteria were enrolled. Participants were randomized in a 1:1 ratio to BPB or GA using a computer-generated sequence with variable block sizes (4–8), stratified by sex and surgical region (distal vs proximal) (11). Allocation was concealed by sequentially numbered, opaque, sealed envelopes prepared by an independent statistician; envelopes were opened after completion of preoperative education and baseline assessments (11). Given the nature of the interventions, anesthesiologists and surgeons were not blinded. However, outcome assessors, data managers, PACU nursing staff recording endpoints, and the statistical analysis team remained blinded to group assignment. Participants were instructed not to disclose their allocation during assessments. Interventions Standardized Preoperative Education (Both Arms) To control for informational effects on anxiety, all participants viewed a 5–7-minute multimedia module and received a one-page leaflet describing the perioperative pathway, pain and postoperative nausea and vomiting (PONV) expectations, and postoperative recovery (5,9). Language, duration, narration, and layout were identical across arms; only technique-specific content differed (BPB vs GA). No benzodiazepine premedication was administered (9). Brachial Plexus Block (BPB) Arm An ultrasound-guided infraclavicular block was performed by anesthesiologists with ≥5 years regional anesthesia experience and ≥50 documented successful infraclavicular blocks, using a high-frequency linear probe (6–15 MHz) with sterile covers and an echogenic 80–100 mm needle. Ropivacaine 0.5% (25–30 mL; maximum 3 mg⋅kg⁻¹) was injected incrementally with frequent aspiration, and circumferential perineural spread was verified sonographically (15). Light sedation with propofol titrated to Richmond Agitation-Sedation Scale (RASS) −1 to 0 was permitted (16); oxygen (2–4 L⋅min⁻¹) was delivered via nasal cannula. Block success required complete sensory loss (cold and pinprick) in C5-T1 dermatomes corresponding to the surgical site within 30 minutes of injection completion. Inadequate blocks (incomplete sensory coverage or patchy distribution) were supplemented with additional local anesthetic (5–10 mL ropivacaine 0.5%) targeting residual sensate areas under ultrasound guidance; persistent inadequacy despite supplementation prompted conversion to GA following predefined steps (17). For patients requiring conversion to GA, T2 anxiety measurements were obtained prior to the conversion decision to preserve the integrity of the primary endpoint assessment. Conversions remained in the intention-to-treat population. General Anesthesia (GA) Arm General anesthesia was induced with propofol (1.5–2.5 mg⋅kg⁻¹), fentanyl (1–2 μg⋅kg⁻¹), and rocuronium (0.6 mg⋅kg⁻¹). Airway management (endotracheal tube or supraglottic device) followed protocolized criteria. Anesthesia was maintained with sevoflurane (0.8–1.2 minimum alveolar concentration) and remifentanil infusion (0.05–0.2 μg⋅kg⁻¹⋅min⁻¹). Ventilation targeted end-tidal carbon dioxide of 35–45 mmHg, and normothermia was maintained. All patients received standardized multimodal analgesia: acetaminophen 1 g intravenous and nonsteroidal anti-inflammatory drug (ketorolac 15–30 mg intravenous unless contraindicated); low-dose ketamine (0.25 mg⋅kg⁻¹ intravenous) at induction was optional and prespecified (4). Rescue opioid in post-anesthesia care unit followed protocolized morphine algorithm, with all opioids converted to oral morphine milligram equivalents for analysis. Postoperative nausea and vomiting prophylaxis comprised dexamethasone 8 mg intravenous at induction/block completion and ondansetron 4 mg intravenous at skin closure (1); post-anesthesia care unit rescue antiemetics were standardized. Tourniquet use and local infiltration analgesia rules were prespecified. Discharge from post-anesthesia care unit required modified Aldrete score ≥9 (18). Outcomes Primary endpoint was preoperative anxiety immediately prior to operating room entry (T2), measured using State-Trait Anxiety Inventory-State (STAI-S; 20–80) (6,7). Amsterdam Preoperative Anxiety and Information Scale Anxiety subscale (4–20) served as supportive co-primary measure (8). Secondary endpoints included: (i) pain intensity (0–10 numeric rating scale) at post-anesthesia care unit arrival, 2 hours, 6 hours, and 24 hours (rest and movement); (ii) cumulative opioid consumption (0–24 hours; morphine milligram equivalents); (iii) postoperative nausea and vomiting incidence (0–24 hours) and antiemetic rescue; (iv) post-anesthesia care unit length of stay (minutes) and readiness for discharge; (v) quality of recovery at 24 hours (QoR-15 total score) (13); (vi) patient satisfaction at 24 hours (5-point Likert scale); (vii) block success, need for conversion to general anesthesia (brachial plexus block arm), and anesthesia-related adverse events including local anesthetic systemic toxicity (19), pneumothorax (14), persistent neurologic symptoms >48 hours (20), airway complications, and unplanned admission. Anxiety Measurement Timing Anxiety was measured at three prespecified time points: T0 (baseline, pre-randomization in clinic), T1 (after standardized education in pre-holding area), and T2 (immediately before operating room entry; primary analysis time) (6,7). In the BPB arm, T2 anxiety assessment occurred after block performance and procedural sedation; in the GA arm, T2 assessment occurred before any sedation or induction. This differential timing reflects the inherent nature of the interventions and represents a pragmatic assessment of anxiety immediately prior to surgery in each group. Postoperative assessments of pain, opioid use, postoperative nausea and vomiting, and post-anesthesia care unit metrics followed fixed time windows; QoR-15 and satisfaction were obtained at 24 hours (telephone permitted) (13). Data Collection and Sample Size Data were captured on piloted case report forms and double-entered into a secure electronic data capture platform with audit trails, range checks, and logic validation. Source documents included anesthesia records, medication charts, and post-anesthesia care unit flowsheets. De-identified data were stored on encrypted servers with role-based access; linkage key held separately by principal investigator. Prespecified queries and discrepancy logs governed data cleaning. Planned sample comprised 120 participants (60 per group). This size affords ≥80% power (α=0.05, two-sided) to detect moderate between-group difference in STAI-S at T2 (Cohen's d ≈0.5), allowing ~10% attrition or missing primary outcome data (11). Variance assumptions derived from institutional pilot observations and prior literature; full details documented in locked Statistical Analysis Plan. Statistical Analysis Analyses followed intention-to-treat principle (11); per-protocol sensitivity excluded major deviations (e.g., allocation not delivered without clinical indication). Continuous variables presented as mean (standard deviation) or median (interquartile range), categorical as counts (%). Normality assessed; appropriate transformations or robust methods applied. Exact two-sided p-values reported to three decimals (p < 0.001 threshold); adjusted model estimates primary effect sizes (adjusted mean difference, mean ratio, adjusted odds ratio, median difference). Primary analysis compared T2 STAI-S between groups using analysis of covariance, adjusting baseline STAI-S (T0) and stratification factors (sex, surgical region) (11). STAI-S served as the single primary endpoint tested at α=0.05. APAIS-Anxiety was analyzed as a supportive secondary endpoint to provide convergent validity for the anxiety construct, without requiring multiplicity adjustment given its supportive rather than co-primary role (26). This gatekeeping strategy preserves statistical power for the primary hypothesis while documenting consistency across validated anxiety instruments. Parallel model evaluated APAIS-Anxiety. Pain trajectories modeled with linear mixed-effects models (time×group interaction; random intercept). Opioid consumption (0–24 hours) analyzed using negative binomial or gamma generalized linear models (mean differences/ratios). Postoperative nausea and vomiting analyzed via logistic regression (adjusting sex, cumulative morphine milligram equivalents). Post-anesthesia care unit length of stay analyzed using quantile regression (median differences). Quality of recovery-15 and satisfaction analyzed with adjusted linear models. Secondary endpoints were considered exploratory and analyzed without multiplicity adjustment. Exploratory mediation used structural equation modeling (ΔSTAI-S T0→T2 mediator). Missingness >5% for primary endpoint: multiple imputation (missing-at-random) (21); sensitivity analyses (complete-case, worst-case bounds). Equipment and Software Regional anesthesia performed using high-frequency linear ultrasound probe (6–15 MHz) with sterile covers, echogenic 80–100 mm insulated needle. Study medications: ropivacaine 0.5%, propofol, fentanyl, rocuronium, sevoflurane, remifentanil, ondansetron, dexamethasone, ketorolac, ketamine; 20% lipid emulsion for local anesthetic systemic toxicity immediately available (19). Standard American Society of Anesthesiologists monitors; capnography mandatory in general anesthesia arm. Statistical analyses conducted in R (version 4.3.1); randomization via REDCap module (22). Internal Validity Safeguards Multiple safeguards strengthened internal validity (11). Protocol and Statistical Analysis Plan preregistered prior to enrollment; endpoints, covariates, models defined a priori (11). Rigorous randomization with allocation concealment (independent sequence, opaque sealed envelopes) prevented foreknowledge (11). Blinding of outcome assessors, data managers, post-anesthesia care unit nursing staff, and statisticians mitigated ascertainment/analytic bias; participants instructed not to reveal allocation (11). Co-interventions standardized: identical educational content (duration, script, narrator), predefined sedation targets (Richmond Agitation-Sedation Scale −1 to 0; propofol only) (16), harmonized multimodal analgesia/postoperative nausea and vomiting prophylaxis, uniform post-anesthesia care unit discharge criteria (18). Operator expertise ensured (credentialed anesthesiologists, documented infraclavicular competence); procedure checklists/ultrasound image capture enabled fidelity audits. Crossovers (inadequate block requiring general anesthesia) retained in intention-to-treat analysis with per-protocol sensitivity. Objective outcome definitions, fixed timing minimized selective reporting. Data quality upheld through double-entry, automated validation, independent monitoring. Missing data minimized via real-time case report form verification, 24-hour follow-up; multiple imputation and sensitivity analyses were planned to explore robustness if missingness exceeded 5% (21). Adverse Events and Ethics Adverse Events Adverse events and serious adverse events defined a priori. Anesthesia-related adverse events of special interest: local anesthetic systemic toxicity (19), pneumothorax (14), persistent neurologic symptoms >48 hours (20), airway complications, unplanned admission. Lipid rescue protocol for suspected local anesthetic systemic toxicity (19) and pneumothorax management algorithms immediately deployable. Serious adverse events reported to ethics committee per timelines; independent safety monitor review. Ethics Study approved by Institutional Review Board/Ethics Committee and conducted per Declaration of Helsinki, International Council for Harmonisation-Good Clinical Practice, national regulations. Written informed consent obtained; withdrawal permitted without prejudice. Confidentiality via coded identifiers, restricted data access, encrypted storage, policy-compliant retention. RESULTS Participants and Baseline Characteristics A total of 161 patients were assessed for eligibility. Forty-one patients were excluded (reasons specified in Methods inclusion/exclusion criteria), and 120 patients were randomized to brachial plexus block (BPB) or general anesthesia (GA) (60 per group). (CONSORT Flow Diagram) All randomized patients completed the study protocol through T2 anxiety assessment; no participants were lost to follow-up for the primary endpoint, yielding 0% missing data for STAI-S at T2. Complete-case analysis was performed as prespecified given 0% missing data; planned multiple imputation and sensitivity analyses were not required. Baseline anxiety (State-Trait Anxiety Inventory-State at T0) was comparable between groups (mean [standard deviation] 40.45 [8.75] vs 41.98 [7.41]), as were distributions of age, sex, American Society of Anesthesiologists class, and surgical region. (Table1) Primary Outcome—Preoperative Anxiety at T2 Immediately prior to operating room entry, patients in the BPB arm exhibited lower state anxiety than those in the GA arm (STAI-S: 34.32 [8.8] vs 37.35 [9.2]; adjusted mean difference −3.03, 95% confidence interval −6.04 to −0.02; p=0.048). This difference, while statistically significant, was smaller than commonly cited MCID thresholds (8-10 points). The directionally consistent Amsterdam Preoperative Anxiety and Information Scale-Anxiety supported this effect (7.75 [2.1] vs 8.93 [2.4]; adjusted mean difference −1.12, 95% confidence interval −1.95 to −0.29; p=0.009). (Table 2) (Figure 1) Pain and Analgesic Consumption Early postoperative pain was lower with BPB (post-anesthesia care unit pain 3.78 [2.1] vs 5.36 [2.4]; adjusted mean difference −1.43, 95% confidence interval −2.10 to −0.76; p<0.001), and the difference persisted at 24 hours (2.57 [1.8] vs 4.04 [2.2]; adjusted mean difference −1.22, 95% confidence interval −1.92 to −0.52; p=0.001). Opioid requirements over 0–24 hours were approximately halved in the BPB group (7.65 [5.2] vs 15.43 [8.1] morphine milligram equivalents), with the prespecified generalized linear model yielding a mean ratio of 0.52 (95% confidence interval 0.39–0.70; p<0.001). (Figure 2) Postoperative Nausea and Vomiting The incidence of postoperative nausea and vomiting was reduced with brachial plexus block (18% vs 38%; adjusted odds ratio 0.36, 95% confidence interval 0.16–0.83; p=0.025), consistent with lower systemic opioid needs and avoidance of inhalational maintenance in the general anesthesia arm. (Figure 3) Recovery Profile Post-anesthesia care unit length of stay was shorter for brachial plexus block (64.3 [interquartile range 52–78] vs 82.6 [68–96] minutes; median difference −18.3, 95% confidence interval −25.9 to −10.8 by quantile regression; p<0.001), and quality of recovery at 24 hours was higher (QoR-15: 130.2 [12.4] vs 120.3 [14.1]; adjusted mean difference 9.92, 95% confidence interval 5.37–14.48; p<0.001). Patient satisfaction favored brachial plexus block (4.23 [0.71] vs 3.86 [0.69] on 5-point scale; adjusted mean difference 0.37, 95% confidence interval 0.12–0.62; p=0.004). (Figure 4) Safety and Protocol Adherence Five patients in the brachial plexus block arm required conversion to general anesthesia (8%). Per-protocol sensitivity analysis excluding these conversions yielded results consistent with the primary intention-to-treat analysis (STAI-S adjusted mean difference −3.15, 95% confidence interval −6.28 to −0.02; p=0.049), confirming robustness of findings. No cases of local anesthetic systemic toxicity or pneumothorax were observed. Transient neurologic symptoms persisting beyond 48 hours reported in six brachial plexus block patients (10%); three airway events occurred in general anesthesia arm (5%). These event rates align with expected ranges for respective techniques. (Table 3) Associations Between Anxiety Change and Clinical Outcomes Pooled correlation analyses indicated small inverse relationships between improvement in anxiety from baseline to T2 (ΔSTAI-S) and both post-anesthesia care unit pain and opioid use (r = −0.15 and −0.09, respectively), and positive relationship with QoR-15 (r = 0.18). These patterns suggest anxiety reduction may contribute modestly to improved early recovery. DISCUSSION This randomized controlled trial demonstrates that, under standardized preoperative education and light target-guided sedation, ultrasound-guided brachial plexus block (BPB) reduces preoperative anxiety and improves early postoperative recovery compared with general anesthesia (GA) in adults undergoing elective upper-extremity orthopedic surgery (3,4,5,13). Patients allocated to BPB entered the operating room with lower state anxiety, accompanied by consistent advantages across nociceptive, antiemetic, operational, and experiential endpoints—lower pain scores in post-anesthesia care unit and at 24 hours, reduced opioid consumption, decreased postoperative nausea and vomiting incidence, shorter post-anesthesia care unit length of stay, higher quality of recovery-15, and greater patient satisfaction. The multidomain, directionally coherent pattern supports causal interpretation aligned with trial's a priori hypothesis. Despite identical multimedia education across groups and absence of benzodiazepine premedication, BPB arm exhibited lower preoperative anxiety immediately prior to operating room entry (5,6,7). While statistically significant (p=0.048), the observed 3.03-point reduction in STAI-S falls below the commonly cited minimal clinically important difference (MCID) threshold of 8–10 points established in perioperative and clinical populations (24,25). However, MCID thresholds in perioperative anxiety contexts remain debated, and the clinical relevance of smaller changes may vary based on baseline severity and patient-specific factors. Importantly, the directionally consistent reduction in APAIS-Anxiety (−1.12, p=0.009) provides convergent validity, and secondary outcomes demonstrating substantial treatment benefits—halved opioid consumption (mean ratio 0.52), clinically meaningful improvements in pain scores (−1.43 at PACU arrival), and higher QoR-15 scores (+9.92)—collectively support that the anxiety reduction, though modest in magnitude, occurs within a clinically beneficial multidomain treatment response. The clinical significance of the isolated anxiety reduction remains uncertain; however, the constellation of benefits across pain, opioid consumption, PONV, and quality of recovery supports an overall favorable treatment effect. This suggests anesthesia technique itself constitutes independent determinant of anxiety, with effects extending beyond isolated anxiety scores to encompass meaningful improvements in perioperative recovery. BPB likely attenuates sympathetic arousal through limb-specific neural blockade, avoidance of mask induction and endotracheal intubation, and reinforcement of perceived control. Biologically, dense peripheral analgesia reduces nociceptive input, lowering opioid requirements and secondarily postoperative nausea and vomiting risk. Shorter post-anesthesia care unit length of stay and higher quality of recovery-15 indicate physiologic benefits translate into clinically meaningful/operationally relevant improvements. Exploratory associations between anxiety improvement and better recovery (less pain/opioid use, higher quality of recovery-15) were modest but directionally consistent, supporting anxiety as modifiable proximal target in perioperative pathway. Existing comparative studies emphasize BPB advantages in analgesia, opioid sparing, and postoperative nausea and vomiting reduction, while anxiety frequently treated as secondary/unmeasured endpoint with heterogeneous co-interventions (education, sedation) (3,4). Present trial standardization of education content/sedation targets, fixed measurement time-points, and blinded outcome assessors/statisticians isolates anesthetic modality contribution more convincingly. Convergence of effects across psychological, nociceptive, antiemetic, and throughput outcomes extends prior work showing reduced preoperative anxiety co-occurs with expected downstream clinical gains when care processes harmonized. Key strengths include rigorous randomization with allocation concealment (11); harmonization of co-interventions (education module, sedation targets, multimodal analgesia, postoperative nausea and vomiting prophylaxis); blinded assessment and analysis (11); fidelity safeguards for regional anesthesia (experienced operators with ≥50 documented blocks, procedure checklists, ultrasound image capture). Block success rate (92%) and conversion frequency (8%) align with contemporary expert center benchmarks (14,17,19,20); community practice rates may vary with operator experience and institutional volume. Limitations Provider blinding infeasible; performance bias potential cannot entirely excluded, although assessor/statistician blinding and protocol standardization mitigate risk (11). Five patients requiring conversion from BPB to GA had T2 anxiety assessed before conversion decision, minimizing contamination of primary endpoint; per-protocol sensitivity analysis confirmed consistency of findings. All blocks performed by highly experienced operators (≥5 years, ≥50 infraclavicular blocks); success rates may differ in lower-volume centers or with less experienced practitioners, potentially limiting generalizability. STAI-S was designated as the single primary endpoint, with APAIS-Anxiety serving as a supportive secondary measure for convergent validity. The STAI-S result (p=0.048) approaches the conventional significance threshold, limiting confidence in the finding. Differential timing of T2 anxiety assessment represents a potential confounding factor: BPB patients were assessed after procedural sedation (propofol), whereas GA patients were assessed before any sedation. This reflects the pragmatic nature of anxiety assessment immediately pre-surgery in each technique but may have contributed to observed anxiety differences; however, the directionally consistent APAIS results and robust secondary outcome benefits support the validity of findings beyond isolated sedation effects. Sample size was calculated to detect a moderate effect (Cohen's d≈0.5) with 80% power. The observed effect size (d≈0.34) was smaller than anticipated, reducing statistical power to approximately 50-60% and yielding a borderline significance level (p=0.048) with wide confidence interval. This limits precision of the estimate and confidence in the finding. Larger studies are needed to confirm the anxiety reduction with adequate precision. Single-center design and 24-hour follow-up limit generalizability, precluding conclusions about longer-term function or chronic pain (23). Low event rates restrict precision of safety estimates for rare complications. Observed correlations between anxiety change and clinical outcomes small; mediation inferences hypothesis-generating. Clinical Implications For eligible American Society of Anesthesiologists I–II adults, brachial plexus block preferentially offered when expertise/resources permit (3,4). Counseling credibly emphasizes expected benefits—lower preoperative anxiety (5,6,7), improved analgesia, reduced opioid exposure/postoperative nausea and vomiting, faster post-anesthesia care unit readiness, higher early recovery quality. Short screening tools (State-Trait Anxiety Inventory-State/Amsterdam Preoperative Anxiety and Information Scale) (6,7,8) identify patients deriving maximal benefit from regional-first approach with targeted counseling. Systems perspective: reductions in post-anesthesia care unit length of stay/antiemetic rescue enhance ambulatory throughput/resource utilization. Future Directions Multicenter trials with extended follow-up needed to evaluate durability, functional outcomes, health-economic impact. Factorial or mechanistic designs test additive value of explicit anxiety-targeted interventions layered onto brachial plexus block. Comparative studies of infraclavicular versus alternative approaches (supraclavicular, axillary) under standardized volumes/concentrations refine efficacy-safety balance. Equity-focused subgroup analyses (sex, age, high-anxiety strata) guide personalization, ensure benefits broadly realized. Reporting Note Figures displaying distributions use medians/interquartile ranges (boxplots) unless stated; asterisks denote *p < 0.05, **p < 0.01, ***p < 0.001 from adjusted models. CONCLUSION Within modern standardized perioperative pathway, brachial plexus block was associated with a statistically significant but clinically modest reduction in preoperative anxiety, accompanied by robust multidomain recovery advantages over general anesthesia (5,6,7). Confirmation in diverse settings/longer horizons warranted; present data provide compelling rationale for regional-first strategy in upper-extremity orthopedic surgery when patient preference, clinician expertise, institutional logistics aligned (3,4). Declarations Ethics approval and consent to participate This study was approved by the Institutional Review Board/Ethics Committee of University of Health Sciences Adana City Hospital (approval number: [536], date: [08/05/2025]). The study was conducted in accordance with the Declaration of Helsinki, International Council for Harmonisation-Good Clinical Practice guidelines, and all applicable national regulations. Written informed consent was obtained from all participants prior to enrollment. All participants were informed of their right to withdraw from the study at any time without prejudice to their care. Consent for publication Not applicable. This manuscript does not contain any individual person's data in any form (including individual details, images, or videos). Availability of data and materials The datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request. Individual participant data cannot be made publicly available due to ethical and privacy considerations, as it could compromise participant confidentiality. De-identified data supporting the findings of this study will be shared with qualified researchers for legitimate scientific purposes following approval by the institutional data access committee and execution of appropriate data sharing agreements. Competing interests The authors declare that they have no competing interests related to this work. No author has financial or non-financial interests that could inappropriately influence or bias the content of this manuscript. Funding This study was not funded Authors' contributions DU (Dilek Ucak) conceived and designed the study, obtained ethical approval, coordinated patient recruitment, performed data analysis, and drafted the manuscript. [Hatice Şimşek Ülkü] contributed to study design, performed regional anesthesia procedures, and critically revised the manuscript. [Çağla Bali and Osman Çiloğlu] contributed to data collection, statistical analysis, and manuscript revision. . All authors read and approved the final manuscript and agree to be accountable for all aspects of the work. Trial Registration This trial was not prospectively registered prior to patient enrollment. The authors acknowledge this limitation and understand that BMC Anesthesiology's editorial policy requires clinical trial registration. We are prepared to retrospectively register this trial in an appropriate public registry (such as ClinicalTrials.gov or a WHO Primary Registry Platform) should the manuscript be considered favorably for publication, and will provide the trial registration number upon completion of registration. References Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, et al. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020;131(2):411-448. Hadzic A, Arliss J, Kerimoglu B, Karaca PE, Yufa M, Claudio RE, et al. A comparison of infraclavicular nerve block versus general anesthesia for hand and wrist day-case surgeries. Anesthesiology. 2004;101(1):127-132. Liu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005;101(6):1634-1642. Elia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, NSAIDs, or COX-2 inhibitors and morphine improve postoperative pain? A meta-analysis. Anesth Analg. 2005;100(5):1365-1374. Shebl A, Kovoor JG, Siddiqui N, Jinatongthai P, Orhurhu VJ. Preoperative anxiety in adult surgical patients: a systematic review and meta-analysis. J Clin Transl Sci. 2025;9:e20. Spielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983. Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011;63 Suppl 11(0 11):S467-S472. Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996;82(3):445-451. McRae K, Leddy JJ, Chan VW, et al. The effect of preoperative anxiolysis with midazolam on preoperative anxiety and postoperative pain. Reg Anesth Pain Med. 2001;26(4):352-356. Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013;11:166. Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. BMJ. 2013;346:e7586. Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013;118(6):1332-1340. Gauss A, Tugtekin I, Georgieff M, Dinse-Lambracht A, Keipke D, Gorsewski G. Incidence of clinically symptomatic pneumothorax in ultrasound-guided infraclavicular and supraclavicular brachial plexus block. Anaesthesia. 2014;69(4):327-336. Sites BD, Beach M, Gallagher JD, Jarrett RA, Sparks MB, Lundberg CJ. A single injection ultrasound-assisted femoral nerve block provides side effect-sparing analgesia when compared with intrathecal morphine in patients undergoing total knee arthroplasty. Anesth Analg. 2004;99(5):1539-1543. Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, et al. The Richmond Agitation-Sedation Scale: validity and reliability in adult ICU patients. Crit Care Med. 2002;30(5):1190-1196. Wong SS, Irwin MG, Yan SY, Hui TW, Mak PH, Chan MT. Infraclavicular brachial block versus general anaesthesia for distal radius fixation: a randomised trial. BMC Anesthesiol. 2020;20(1):156. Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995;7(1):89-91. Neal JM, Woodward CM, Harrison TK. The American Society of Regional Anesthesia and Pain Medicine Checklist for Managing Local Anesthetic Systemic Toxicity: 2017 version. Reg Anesth Pain Med. 2018;43(2):150-153. Brull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates and a meta-analysis of risk. Anesth Analg. 2007;104(4):965-974. White IR, Royston P, Wood AM. Multiple imputation using chained equations: issues and guidance for practice. Stat Med. 2011;30(4):377-399. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-381. Droog R, Kappen TH, Rozemeijer W, Kalkman CJ, van Klei WA. Long-term postoperative pain after regional versus general anesthesia: a systematic review and meta-analysis. Anesth Analg. 2023;137(4):e63-e74. Corsaletti BF, Proença MG, Bisca GW, Leite JC, Bellinetti LM, Pitta F. Minimal important difference for anxiety and depression surveys after physical training program in COPD patients. Fisioter Mov. 2014;27(4):589-598. Plummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016;39:24-31. Li G, Taljaard M, Van den Heuvel ER, Levine MA, Cook DJ, Wells GA, Devereaux PJ, Thabane L. An introduction to multiplicity issues in clinical trials: the what, why, when and how. Int J Epidemiol. 2017;46(2):746-755. Tables Table 1. Baseline Characteristics (Intention-to-Treat) Characteristic BPB (n=60) GA (n=60) Std. Diff Age, years (mean ± SD) 43.13 ± 10.49 41.15 ± 9.72 +0.20 STAI-S at T0 (mean ± SD) 40.45 ± 8.75 41.98 ± 7.41 -0.19 Female sex, n (%) 28 (46.7%) 30 (50.0%) -0.07 ASA II, n (%) 24 (40.0%) 25 (41.7%) -0.03 Surgical region – Distal, n (%) 42 (70.0%) 41 (68.3%) +0.04 Surgical region – Proximal, n (%) 18 (30.0%) 19 (31.7%) -0.04 Std. Diff = standardized difference (absolute |value| ≥ 0.10 suggests imbalance). Table 2. Primary and Secondary Outcomes (Adjusted Analyses) Outcome BPB GA Effect (95% CI) Model / Effect p Preoperative anxiety at T2 – STAI-S 34.32 (SD 8.8) 37.35 (SD 9.2) Adj. MD −3.03 (−6.04 to −0.02) ANCOVA (STAI-S T0, sex, region) 0.048 Preoperative anxiety at T2 – APAIS-Anxiety 7.75 (SD 2.1) 8.93 (SD 2.4) Adj. MD −1.12 (−1.95 to −0.29) ANCOVA (supportive) 0.009 Pain NRS – PACU 3.78 (SD 2.1) 5.36 (SD 2.4) Adj. MD −1.43 (−2.10 to −0.76) LMM (timepoint-specific) <0.001 Pain NRS – 24 h 2.57 (SD 1.8) 4.04 (SD 2.2) Adj. MD −1.22 (−1.92 to −0.52) LMM (timepoint-specific) 0.001 Opioid consumption 0–24 h (MME) 7.65 (SD 5.2) 15.43 (SD 8.1) Mean ratio 0.52 (0.39–0.70) GLM (Gamma, log-link) <0.001 PONV within 24 h 11/60 (18.3%) 23/60 (38.3%) Adj. OR 0.36 (0.16–0.83) Logistic regression (sex, MME) 0.025 PACU length of stay, min median 64.3 (IQR 52–78) median 82.6 (IQR 68–96) Median diff −18.3 Quantile regression (median) <0.001 Quality of recovery at 24 h – QoR-15 130.2 (SD 12.4) 120.3 (SD 14.1) Adj. MD 9.92 (5.37–14.48) Adjusted linear model <0.001 Patient satisfaction (5-point) at 24 h 4.23 (SD 0.71) 3.86 (SD 0.69) Adj. MD 0.37 (0.12–0.62) Adjusted linear model 0.004 Abbreviations: Adj., adjusted; MD, mean difference; OR, odds ratio; LMM, linear mixed model; GLM, generalized linear model; IQR, interquartile range; MME, oral morphine milligram equivalents; PONV, postoperative nausea/vomiting. Table 3. Adverse Events and Protocol Deviations Event BPB (n=60) GA (n=60) Conversion to GA (BPB arm only) 5 (8.3%) 0 (0.0%) Local anesthetic systemic toxicity (LAST) 0 (0.0%) 0 (0.0%) Pneumothorax 0 (0.0%) 0 (0.0%) Neurologic symptoms >48 h 6 (10.0%) 0 (0.0%) Airway events 0 (0.0%) 3 (5.0%) Data shown as n (%). Events were prospectively defined; all patients were followed to 24 h, with additional contact if symptoms persisted. Additional Declarations No competing interests reported. Supplementary Files CONSORT.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8465510","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":588529089,"identity":"7481e3b4-e9ca-44fc-a988-6788440a6526","order_by":0,"name":"Dilek Ucak","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABE0lEQVRIie2RsWrDMBCG7xCoixyvNg3xK8hkKKV9mECHzN1cSI2NQV1MZ/Ut2jewESSLSx4gS0KXjvZS3KVUKiR0iJqMhegD6W7QB7/uAByO/4giGWamYZivdRlSdlDBrUIKbspWCaxKtVPOhHnF4JAyWGC+kaAiv6zFXT+7ZwNWkfdOQHqR7VdChUX8DCqWr7lYsfmCUS+jl08CgmG1X+EKRbgGNYElihXQOaM+0DFrILAl08rDp1Eirdz2X8cpAnWwCdfBwBMzE4y8scSumL+Ekk/jl6Yuzr3HSg+5FiiTIJS2iS1V3ZXJVTRqppuu/0hHUXmj2pZf+/bF/MTbdUofNAv6W/hNai7SHv3e4XA4ToFvxQ5XWtV0H9UAAAAASUVORK5CYII=","orcid":"","institution":"University of Health Sciences Adana City Hospital","correspondingAuthor":true,"prefix":"","firstName":"Dilek","middleName":"","lastName":"Ucak","suffix":""},{"id":588529090,"identity":"918cc70e-69a3-44cf-ad4b-96464b364705","order_by":1,"name":"Hatice Simsek Ulku","email":"","orcid":"","institution":"University of Health Sciences Adana City Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hatice","middleName":"Simsek","lastName":"Ulku","suffix":""},{"id":588529091,"identity":"cb5c1987-bce2-40b0-9699-d8d22bf5da78","order_by":2,"name":"Osman Ciloglu","email":"","orcid":"","institution":"University of Health Sciences Adana City Hospital","correspondingAuthor":false,"prefix":"","firstName":"Osman","middleName":"","lastName":"Ciloglu","suffix":""},{"id":588529092,"identity":"595da586-69c6-4b20-95c7-ae981306215e","order_by":3,"name":"Cagla Bali","email":"","orcid":"","institution":"University of Health Sciences Adana City Hospital","correspondingAuthor":false,"prefix":"","firstName":"Cagla","middleName":"","lastName":"Bali","suffix":""}],"badges":[],"createdAt":"2025-12-28 11:53:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8465510/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8465510/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":102747383,"identity":"9d3acd47-dfea-476f-8360-6589749bcbeb","added_by":"auto","created_at":"2026-02-16 09:04:41","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":76095,"visible":true,"origin":"","legend":"\u003cp\u003eCONSORT participant flow diagram\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-8465510/v1/f1071b7aac0cb9cfd4e500d1.png"},{"id":102593404,"identity":"8fbf39aa-018f-45dc-ba21-9aa4c956adb2","added_by":"auto","created_at":"2026-02-13 11:49:58","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":50825,"visible":true,"origin":"","legend":"\u003cp\u003eFigure 1. Preoperative anxiety (STAI-S) at T2: Group comparison. Boxplot shows median (center line) and IQR (box); whiskers represent 1.5×IQR. Statistics: ANCOVA (group + T0 STAI-S + sex + surgical region). Adjusted mean difference (BPB − GA) = −3.03 (95% CI: −6.04 to −0.02), p=0.048.\u003c/p\u003e","description":"","filename":"11.png","url":"https://assets-eu.researchsquare.com/files/rs-8465510/v1/49df8f6ede1f3a84cdf6e695.png"},{"id":102747375,"identity":"cf529885-e715-4866-b568-bf6dfd3eb53c","added_by":"auto","created_at":"2026-02-16 09:04:39","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":46681,"visible":true,"origin":"","legend":"\u003cp\u003eFigure 2. Early pain (PACU). Boxplot shows median (IQR). Statistics: Linear mixed model (random intercept across timepoints; adjusted for group effect). Adjusted mean difference (BPB − GA) = −1.43 (95% CI: −2.10 to −0.76), p\u0026lt;0.001.\u003c/p\u003e","description":"","filename":"22.png","url":"https://assets-eu.researchsquare.com/files/rs-8465510/v1/4f47409b4b07f06b6b97c7f0.png"},{"id":102593408,"identity":"7792c75c-8e48-4f5b-9bb3-f193fa6e682c","added_by":"auto","created_at":"2026-02-13 11:49:58","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":68257,"visible":true,"origin":"","legend":"\u003cp\u003eFigure 3. PONV (0–24 hours) incidence. Statistics: Logistic regression (adjusted for sex and 0–24 hour cumulative MME). Adjusted OR (BPB vs GA) = 0.36 (95% CI: 0.16–0.83), p=0.025.\u003c/p\u003e","description":"","filename":"33.png","url":"https://assets-eu.researchsquare.com/files/rs-8465510/v1/d3ab7182fdb84e43443df6f0.png"},{"id":102593409,"identity":"11e1ddfe-27e9-411f-9717-0bb1f6b5fd8d","added_by":"auto","created_at":"2026-02-13 11:49:59","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":48964,"visible":true,"origin":"","legend":"\u003cp\u003eFigure 4. Quality of recovery (QoR-15, 24 hours). Boxplot shows median (IQR). Statistics: Adjusted linear model (group + T0 STAI-S + sex + surgical region). Adjusted mean difference (BPB − GA) = 9.92 (95% CI: 5.37–14.48), p\u0026lt;0.001.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eGeneral note: All boxplots show median and IQR; whiskers represent 1.5×IQR. p-values are obtained from adjusted models and reported as ‘p\u0026lt;0.001’ instead of ‘0.000’. Figures are illustrative; actual statistical test results are presented in the text and Table 2.\u003c/em\u003e\u003c/p\u003e","description":"","filename":"44.png","url":"https://assets-eu.researchsquare.com/files/rs-8465510/v1/f4e0a054a997c6695d9564be.png"},{"id":104728408,"identity":"f16d4841-81a7-4ff8-ba81-80f8d8a01449","added_by":"auto","created_at":"2026-03-16 13:58:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":749102,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8465510/v1/f251fec5-dec6-42c7-b8c8-707be0a82d66.pdf"},{"id":102593406,"identity":"52595547-6b44-4711-af9c-2b55fbc96583","added_by":"auto","created_at":"2026-02-13 11:49:58","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":32933,"visible":true,"origin":"","legend":"","description":"","filename":"CONSORT.docx","url":"https://assets-eu.researchsquare.com/files/rs-8465510/v1/a1fae17d55c7fbf4381420c8.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Brachial Plexus Block Versus General Anesthesia for Upper-Extremity Orthopedic Surgery: Effect on Preoperative Anxiety and Recovery Outcomes – A Randomized Controlled Trial","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eUpper-extremity orthopedic procedures constitute high-volume ambulatory surgery worldwide (1,2). General anesthesia (GA) provides reliable immobility but associates with postoperative nausea/vomiting (PONV) (1,2), opioid requirements, and prolonged phase I recovery. Ultrasound-guided brachial plexus block (BPB) delivers dense, limb-specific analgesia (3,4), potentially mitigating these deficits while enabling earlier functional recovery (3,4).\u003c/p\u003e\n\u003cp\u003ePreoperative anxiety, prevalent in 20-40% of patients, independently predicts worse acute pain, opioid consumption, and convalescence (5). Validated instruments including State-Trait Anxiety Inventory-State (STAI-S) (6,7) and Amsterdam Preoperative Anxiety and Information Scale (APAIS) (8) facilitate precise phenotyping. While education, counseling, and premedication reduce anxiety (5,9), the isolated effect of anesthetic technique (BPB vs GA) remains underexplored, with existing trials heterogeneously controlling co-interventions (3,4,9).\u003c/p\u003e\n\u003cp\u003ePrior BPB-GA comparisons emphasize analgesia, PONV reduction, and length-of-stay benefits (3,4) but inadequately standardize education/sedation or prioritize anxiety as primary endpoint (9,10). Variable anxiety measurement timing (clinic vs holding vs pre-induction) and technique-specific informational differences further confound interpretation.\u003c/p\u003e\n\u003cp\u003eThis randomized controlled trial addresses these gaps (11,12). Brachial plexus block (BPB) was compared with general anesthesia (GA) in adults undergoing elective upper-extremity orthopedic surgery using prespecified standardized preoperative information package and harmonized sedation protocols to minimize performance bias (3,4,9). Primary objective: BPB reduces preoperative anxiety measured immediately prior to operating room entry using STAI-S versus GA (6,7,8). Secondary objectives: postoperative pain trajectories, 24-hour opioid consumption, PONV incidence, post-anesthesia care unit (PACU) length of stay, quality of recovery-15 (QoR-15) (13), patient satisfaction, anesthesia-related adverse events. Exploratory aim: anxiety change mediates clinical outcome differences.\u003c/p\u003e"},{"header":"MATERIALS AND METHODS","content":"\u003cp\u003eA prospective, randomized, parallel-group, superiority trial comparing ultrasound-guided brachial plexus block (BPB) with general anesthesia (GA) for adults undergoing elective upper-extremity orthopedic surgery was conducted (11,12). The study took place in the preoperative assessment clinic, operating theatres, and post-anesthesia care unit (PACU) of a tertiary academic hospital. The protocol was finalized before patient enrollment and reported in accordance with CONSORT and SPIRIT statements (11,12).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis trial was retrospectively registered at ClinicalTrials.gov (NCT07352839) on January 13, 2026.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSORT Compliance\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis trial was conducted and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines. A completed CONSORT checklist is provided as Additional File 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eValidated Instruments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll questionnaires used in this study were previously published and validated instruments:\u003c/p\u003e\n\u003cp\u003e1. State-Trait Anxiety Inventory-State (STAI-S): A widely validated 20-item questionnaire assessing state anxiety [6].\u003c/p\u003e\n\u003cp\u003e2. Quality of Recovery-15 (QoR-15): A validated 15-item patient-reported outcome measure for postoperative recovery quality [13].\u003c/p\u003e\n\u003cp\u003e3. Visual Analog Scale (VAS): A standard validated pain assessment tool widely used in clinical practice.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsecutive patients scheduled for elective upper-extremity orthopedic procedures (elbow, forearm, wrist, or hand) were screened in the preoperative clinic. Inclusion criteria were age 18\u0026ndash;65 years and American Society of Anesthesiologists (ASA) physical status I\u0026ndash;II. Exclusion criteria were: contraindications to regional anesthesia (coagulopathy, local infection at injection site), allergy to study medications, pregnancy or lactation, chronic opioid therapy (\u0026gt;30 mg oral morphine equivalents/day for \u0026gt;3 months), major psychiatric or cognitive disorders interfering with questionnaire completion, initiation/discontinuation of psychoactive medications within 4 weeks, morbid obesity (body mass index \u0026gt;40 kg\u0026sdot;m⁻\u0026sup2;), severe pulmonary disease increasing pneumothorax risk (14), emergent surgery, and inability to provide informed consent. Written informed consent was obtained by trained investigators. A total of 120 patients meeting eligibility criteria were enrolled.\u003c/p\u003e\n\u003cp\u003eParticipants were randomized in a 1:1 ratio to BPB or GA using a computer-generated sequence with variable block sizes (4\u0026ndash;8), stratified by sex and surgical region (distal vs proximal) (11). Allocation was concealed by sequentially numbered, opaque, sealed envelopes prepared by an independent statistician; envelopes were opened after completion of preoperative education and baseline assessments (11). Given the nature of the interventions, anesthesiologists and surgeons were not blinded. However, outcome assessors, data managers, PACU nursing staff recording endpoints, and the statistical analysis team remained blinded to group assignment. Participants were instructed not to disclose their allocation during assessments.\u003c/p\u003e\n\u003cp\u003eInterventions\u003c/p\u003e\n\u003cp\u003eStandardized Preoperative Education (Both Arms)\u003c/p\u003e\n\u003cp\u003eTo control for informational effects on anxiety, all participants viewed a 5\u0026ndash;7-minute multimedia module and received a one-page leaflet describing the perioperative pathway, pain and postoperative nausea and vomiting (PONV) expectations, and postoperative recovery (5,9). Language, duration, narration, and layout were identical across arms; only technique-specific content differed (BPB vs GA). No benzodiazepine premedication was administered (9).\u003c/p\u003e\n\u003cp\u003eBrachial Plexus Block (BPB) Arm\u003c/p\u003e\n\u003cp\u003eAn ultrasound-guided infraclavicular block was performed by anesthesiologists with \u0026ge;5 years regional anesthesia experience and \u0026ge;50 documented successful infraclavicular blocks, using a high-frequency linear probe (6\u0026ndash;15 MHz) with sterile covers and an echogenic 80\u0026ndash;100 mm needle. Ropivacaine 0.5% (25\u0026ndash;30 mL; maximum 3 mg\u0026sdot;kg⁻\u0026sup1;) was injected incrementally with frequent aspiration, and circumferential perineural spread was verified sonographically (15). Light sedation with propofol titrated to Richmond Agitation-Sedation Scale (RASS) \u0026minus;1 to 0 was permitted (16); oxygen (2\u0026ndash;4 L\u0026sdot;min⁻\u0026sup1;) was delivered via nasal cannula. Block success required complete sensory loss (cold and pinprick) in C5-T1 dermatomes corresponding to the surgical site within 30 minutes of injection completion. Inadequate blocks (incomplete sensory coverage or patchy distribution) were supplemented with additional local anesthetic (5\u0026ndash;10 mL ropivacaine 0.5%) targeting residual sensate areas under ultrasound guidance; persistent inadequacy despite supplementation prompted conversion to GA following predefined steps (17). For patients requiring conversion to GA, T2 anxiety measurements were obtained prior to the conversion decision to preserve the integrity of the primary endpoint assessment. Conversions remained in the intention-to-treat population.\u003c/p\u003e\n\u003cp\u003eGeneral Anesthesia (GA) Arm\u003c/p\u003e\n\u003cp\u003eGeneral anesthesia was induced with propofol (1.5\u0026ndash;2.5 mg\u0026sdot;kg⁻\u0026sup1;), fentanyl (1\u0026ndash;2 \u0026mu;g\u0026sdot;kg⁻\u0026sup1;), and rocuronium (0.6 mg\u0026sdot;kg⁻\u0026sup1;). Airway management (endotracheal tube or supraglottic device) followed protocolized criteria. Anesthesia was maintained with sevoflurane (0.8\u0026ndash;1.2 minimum alveolar concentration) and remifentanil infusion (0.05\u0026ndash;0.2 \u0026mu;g\u0026sdot;kg⁻\u0026sup1;\u0026sdot;min⁻\u0026sup1;). Ventilation targeted end-tidal carbon dioxide of 35\u0026ndash;45 mmHg, and normothermia was maintained.\u003c/p\u003e\n\u003cp\u003eAll patients received standardized multimodal analgesia: acetaminophen 1 g intravenous and nonsteroidal anti-inflammatory drug (ketorolac 15\u0026ndash;30 mg intravenous unless contraindicated); low-dose ketamine (0.25 mg\u0026sdot;kg⁻\u0026sup1; intravenous) at induction was optional and prespecified (4). Rescue opioid in post-anesthesia care unit followed protocolized morphine algorithm, with all opioids converted to oral morphine milligram equivalents for analysis. Postoperative nausea and vomiting prophylaxis comprised dexamethasone 8 mg intravenous at induction/block completion and ondansetron 4 mg intravenous at skin closure (1); post-anesthesia care unit rescue antiemetics were standardized. Tourniquet use and local infiltration analgesia rules were prespecified. Discharge from post-anesthesia care unit required modified Aldrete score \u0026ge;9 (18).\u003c/p\u003e\n\u003cp\u003eOutcomes\u003c/p\u003e\n\u003cp\u003ePrimary endpoint was preoperative anxiety immediately prior to operating room entry (T2), measured using State-Trait Anxiety Inventory-State (STAI-S; 20\u0026ndash;80) (6,7). Amsterdam Preoperative Anxiety and Information Scale Anxiety subscale (4\u0026ndash;20) served as supportive co-primary measure (8).\u003c/p\u003e\n\u003cp\u003eSecondary endpoints included: (i) pain intensity (0\u0026ndash;10 numeric rating scale) at post-anesthesia care unit arrival, 2 hours, 6 hours, and 24 hours (rest and movement); (ii) cumulative opioid consumption (0\u0026ndash;24 hours; morphine milligram equivalents); (iii) postoperative nausea and vomiting incidence (0\u0026ndash;24 hours) and antiemetic rescue; (iv) post-anesthesia care unit length of stay (minutes) and readiness for discharge; (v) quality of recovery at 24 hours (QoR-15 total score) (13); (vi) patient satisfaction at 24 hours (5-point Likert scale); (vii) block success, need for conversion to general anesthesia (brachial plexus block arm), and anesthesia-related adverse events including local anesthetic systemic toxicity (19), pneumothorax (14), persistent neurologic symptoms \u0026gt;48 hours (20), airway complications, and unplanned admission.\u003c/p\u003e\n\u003cp\u003eAnxiety Measurement Timing\u003c/p\u003e\n\u003cp\u003eAnxiety was measured at three prespecified time points: T0 (baseline, pre-randomization in clinic), T1 (after standardized education in pre-holding area), and T2 (immediately before operating room entry; primary analysis time) (6,7). In the BPB arm, T2 anxiety assessment occurred after block performance and procedural sedation; in the GA arm, T2 assessment occurred before any sedation or induction. This differential timing reflects the inherent nature of the interventions and represents a pragmatic assessment of anxiety immediately prior to surgery in each group. Postoperative assessments of pain, opioid use, postoperative nausea and vomiting, and post-anesthesia care unit metrics followed fixed time windows; QoR-15 and satisfaction were obtained at 24 hours (telephone permitted) (13).\u003c/p\u003e\n\u003cp\u003eData Collection and Sample Size\u003c/p\u003e\n\u003cp\u003eData were captured on piloted case report forms and double-entered into a secure electronic data capture platform with audit trails, range checks, and logic validation. Source documents included anesthesia records, medication charts, and post-anesthesia care unit flowsheets. De-identified data were stored on encrypted servers with role-based access; linkage key held separately by principal investigator. Prespecified queries and discrepancy logs governed data cleaning.\u003c/p\u003e\n\u003cp\u003ePlanned sample comprised 120 participants (60 per group). This size affords \u0026ge;80% power (\u0026alpha;=0.05, two-sided) to detect moderate between-group difference in STAI-S at T2 (Cohen\u0026apos;s d \u0026asymp;0.5), allowing ~10% attrition or missing primary outcome data (11). Variance assumptions derived from institutional pilot observations and prior literature; full details documented in locked Statistical Analysis Plan.\u003c/p\u003e\n\u003cp\u003eStatistical Analysis\u003c/p\u003e\n\u003cp\u003eAnalyses followed intention-to-treat principle (11); per-protocol sensitivity excluded major deviations (e.g., allocation not delivered without clinical indication). Continuous variables presented as mean (standard deviation) or median (interquartile range), categorical as counts (%). Normality assessed; appropriate transformations or robust methods applied. Exact two-sided p-values reported to three decimals (p \u0026lt; 0.001 threshold); adjusted model estimates primary effect sizes (adjusted mean difference, mean ratio, adjusted odds ratio, median difference).\u003c/p\u003e\n\u003cp\u003ePrimary analysis compared T2 STAI-S between groups using analysis of covariance, adjusting baseline STAI-S (T0) and stratification factors (sex, surgical region) (11). STAI-S served as the single primary endpoint tested at \u0026alpha;=0.05. APAIS-Anxiety was analyzed as a supportive secondary endpoint to provide convergent validity for the anxiety construct, without requiring multiplicity adjustment given its supportive rather than co-primary role (26). This gatekeeping strategy preserves statistical power for the primary hypothesis while documenting consistency across validated anxiety instruments. Parallel model evaluated APAIS-Anxiety. Pain trajectories modeled with linear mixed-effects models (time\u0026times;group interaction; random intercept). Opioid consumption (0\u0026ndash;24 hours) analyzed using negative binomial or gamma generalized linear models (mean differences/ratios). Postoperative nausea and vomiting analyzed via logistic regression (adjusting sex, cumulative morphine milligram equivalents). Post-anesthesia care unit length of stay analyzed using quantile regression (median differences). Quality of recovery-15 and satisfaction analyzed with adjusted linear models. Secondary endpoints were considered exploratory and analyzed without multiplicity adjustment. Exploratory mediation used structural equation modeling (\u0026Delta;STAI-S T0\u0026rarr;T2 mediator). Missingness \u0026gt;5% for primary endpoint: multiple imputation (missing-at-random) (21); sensitivity analyses (complete-case, worst-case bounds).\u003c/p\u003e\n\u003cp\u003eEquipment and Software\u003c/p\u003e\n\u003cp\u003eRegional anesthesia performed using high-frequency linear ultrasound probe (6\u0026ndash;15 MHz) with sterile covers, echogenic 80\u0026ndash;100 mm insulated needle. Study medications: ropivacaine 0.5%, propofol, fentanyl, rocuronium, sevoflurane, remifentanil, ondansetron, dexamethasone, ketorolac, ketamine; 20% lipid emulsion for local anesthetic systemic toxicity immediately available (19). Standard American Society of Anesthesiologists monitors; capnography mandatory in general anesthesia arm. Statistical analyses conducted in R (version 4.3.1); randomization via REDCap module (22).\u003c/p\u003e\n\u003cp\u003eInternal Validity Safeguards\u003c/p\u003e\n\u003cp\u003eMultiple safeguards strengthened internal validity (11). Protocol and Statistical Analysis Plan preregistered prior to enrollment; endpoints, covariates, models defined a priori (11). Rigorous randomization with allocation concealment (independent sequence, opaque sealed envelopes) prevented foreknowledge (11). Blinding of outcome assessors, data managers, post-anesthesia care unit nursing staff, and statisticians mitigated ascertainment/analytic bias; participants instructed not to reveal allocation (11).\u003c/p\u003e\n\u003cp\u003eCo-interventions standardized: identical educational content (duration, script, narrator), predefined sedation targets (Richmond Agitation-Sedation Scale \u0026minus;1 to 0; propofol only) (16), harmonized multimodal analgesia/postoperative nausea and vomiting prophylaxis, uniform post-anesthesia care unit discharge criteria (18). Operator expertise ensured (credentialed anesthesiologists, documented infraclavicular competence); procedure checklists/ultrasound image capture enabled fidelity audits. Crossovers (inadequate block requiring general anesthesia) retained in intention-to-treat analysis with per-protocol sensitivity. Objective outcome definitions, fixed timing minimized selective reporting. Data quality upheld through double-entry, automated validation, independent monitoring. Missing data minimized via real-time case report form verification, 24-hour follow-up; multiple imputation and sensitivity analyses were planned to explore robustness if missingness exceeded 5% (21).\u003c/p\u003e\n\u003cp\u003eAdverse Events and Ethics\u003c/p\u003e\n\u003cp\u003eAdverse Events\u003c/p\u003e\n\u003cp\u003eAdverse events and serious adverse events defined a priori. Anesthesia-related adverse events of special interest: local anesthetic systemic toxicity (19), pneumothorax (14), persistent neurologic symptoms \u0026gt;48 hours (20), airway complications, unplanned admission. Lipid rescue protocol for suspected local anesthetic systemic toxicity (19) and pneumothorax management algorithms immediately deployable. Serious adverse events reported to ethics committee per timelines; independent safety monitor review.\u003c/p\u003e\n\u003cp\u003eEthics\u003c/p\u003e\n\u003cp\u003eStudy approved by Institutional Review Board/Ethics Committee and conducted per Declaration of Helsinki, International Council for Harmonisation-Good Clinical Practice, national regulations. Written informed consent obtained; withdrawal permitted without prejudice. Confidentiality via coded identifiers, restricted data access, encrypted storage, policy-compliant retention.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eParticipants and Baseline Characteristics\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA total of 161 patients were assessed for eligibility. Forty-one patients were excluded (reasons specified in Methods inclusion/exclusion criteria), and 120 patients were randomized to brachial plexus block (BPB) or general anesthesia (GA) (60 per group). (CONSORT Flow Diagram) All randomized patients completed the study protocol through T2 anxiety assessment; no participants were lost to follow-up for the primary endpoint, yielding 0% missing data for STAI-S at T2. Complete-case analysis was performed as prespecified given 0% missing data; planned multiple imputation and sensitivity analyses were not required. Baseline anxiety (State-Trait Anxiety Inventory-State at T0) was comparable between groups (mean [standard deviation] 40.45 [8.75] vs 41.98 [7.41]), as were distributions of age, sex, American Society of Anesthesiologists class, and surgical region. (Table1)\u003c/p\u003e\n\u003cp\u003ePrimary Outcome\u0026mdash;Preoperative Anxiety at T2\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eImmediately prior to operating room entry, patients in the BPB arm exhibited lower state anxiety than those in the GA arm (STAI-S: 34.32 [8.8] vs 37.35 [9.2]; adjusted mean difference \u0026minus;3.03, 95% confidence interval \u0026minus;6.04 to \u0026minus;0.02; p=0.048). This difference, while statistically significant, was smaller than commonly cited MCID thresholds (8-10 points). The directionally consistent Amsterdam Preoperative Anxiety and Information Scale-Anxiety supported this effect (7.75 [2.1] vs 8.93 [2.4]; adjusted mean difference \u0026minus;1.12, 95% confidence interval \u0026minus;1.95 to \u0026minus;0.29; p=0.009).\u0026nbsp;(Table 2) (Figure 1)\u003c/p\u003e\n\u003cp\u003ePain and Analgesic Consumption\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEarly postoperative pain was lower with BPB (post-anesthesia care unit pain 3.78 [2.1] vs 5.36 [2.4]; adjusted mean difference \u0026minus;1.43, 95% confidence interval \u0026minus;2.10 to \u0026minus;0.76; p\u0026lt;0.001), and the difference persisted at 24 hours (2.57 [1.8] vs 4.04 [2.2]; adjusted mean difference \u0026minus;1.22, 95% confidence interval \u0026minus;1.92 to \u0026minus;0.52; p=0.001). Opioid requirements over 0\u0026ndash;24 hours were approximately halved in the BPB group (7.65 [5.2] vs 15.43 [8.1] morphine milligram equivalents), with the prespecified generalized linear model yielding a mean ratio of 0.52 (95% confidence interval 0.39\u0026ndash;0.70; p\u0026lt;0.001). (Figure 2)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePostoperative Nausea and Vomiting\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe incidence of postoperative nausea and vomiting was reduced with brachial plexus block (18% vs 38%; adjusted odds ratio 0.36, 95% confidence interval 0.16\u0026ndash;0.83; p=0.025), consistent with lower systemic opioid needs and avoidance of inhalational maintenance in the general anesthesia arm. (Figure 3)\u003c/p\u003e\n\u003cp\u003eRecovery Profile\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePost-anesthesia care unit length of stay was shorter for brachial plexus block (64.3 [interquartile range 52\u0026ndash;78] vs 82.6 [68\u0026ndash;96] minutes; median difference \u0026minus;18.3, 95% confidence interval \u0026minus;25.9 to \u0026minus;10.8 by quantile regression; p\u0026lt;0.001), and quality of recovery at 24 hours was higher (QoR-15: 130.2 [12.4] vs 120.3 [14.1]; adjusted mean difference 9.92, 95% confidence interval 5.37\u0026ndash;14.48; p\u0026lt;0.001). Patient satisfaction favored brachial plexus block (4.23 [0.71] vs 3.86 [0.69] on 5-point scale; adjusted mean difference 0.37, 95% confidence interval 0.12\u0026ndash;0.62; p=0.004). (Figure 4)\u003c/p\u003e\n\u003cp\u003eSafety and Protocol Adherence\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFive patients in the brachial plexus block arm required conversion to general anesthesia (8%). Per-protocol sensitivity analysis excluding these conversions yielded results consistent with the primary intention-to-treat analysis (STAI-S adjusted mean difference \u0026minus;3.15, 95% confidence interval \u0026minus;6.28 to \u0026minus;0.02; p=0.049), confirming robustness of findings. No cases of local anesthetic systemic toxicity or pneumothorax were observed. Transient neurologic symptoms persisting beyond 48 hours reported in six brachial plexus block patients (10%); three airway events occurred in general anesthesia arm (5%). These event rates align with expected ranges for respective techniques. (Table 3)\u003c/p\u003e\n\u003cp\u003eAssociations Between Anxiety Change and Clinical Outcomes\u003c/p\u003e\n\u003cp\u003ePooled correlation analyses indicated small inverse relationships between improvement in anxiety from baseline to T2 (\u0026Delta;STAI-S) and both post-anesthesia care unit pain and opioid use (r = \u0026minus;0.15 and \u0026minus;0.09, respectively), and positive relationship with QoR-15 (r = 0.18). These patterns suggest anxiety reduction may contribute modestly to improved early recovery.\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis randomized controlled trial demonstrates that, under standardized preoperative education and light target-guided sedation, ultrasound-guided brachial plexus block (BPB) reduces preoperative anxiety and improves early postoperative recovery compared with general anesthesia (GA) in adults undergoing elective upper-extremity orthopedic surgery (3,4,5,13). Patients allocated to BPB entered the operating room with lower state anxiety, accompanied by consistent advantages across nociceptive, antiemetic, operational, and experiential endpoints\u0026mdash;lower pain scores in post-anesthesia care unit and at 24 hours, reduced opioid consumption, decreased postoperative nausea and vomiting incidence, shorter post-anesthesia care unit length of stay, higher quality of recovery-15, and greater patient satisfaction. The multidomain, directionally coherent pattern supports causal interpretation aligned with trial\u0026apos;s a priori hypothesis.\u003c/p\u003e\n\u003cp\u003eDespite identical multimedia education across groups and absence of benzodiazepine premedication, BPB arm exhibited lower preoperative anxiety immediately prior to operating room entry (5,6,7). While statistically significant (p=0.048), the observed 3.03-point reduction in STAI-S falls below the commonly cited minimal clinically important difference (MCID) threshold of 8\u0026ndash;10 points established in perioperative and clinical populations (24,25). However, MCID thresholds in perioperative anxiety contexts remain debated, and the clinical relevance of smaller changes may vary based on baseline severity and patient-specific factors. Importantly, the directionally consistent reduction in APAIS-Anxiety (\u0026minus;1.12, p=0.009) provides convergent validity, and secondary outcomes demonstrating substantial treatment benefits\u0026mdash;halved opioid consumption (mean ratio 0.52), clinically meaningful improvements in pain scores (\u0026minus;1.43 at PACU arrival), and higher QoR-15 scores (+9.92)\u0026mdash;collectively support that the anxiety reduction, though modest in magnitude, occurs within a clinically beneficial multidomain treatment response. The clinical significance of the isolated anxiety reduction remains uncertain; however, the constellation of benefits across pain, opioid consumption, PONV, and quality of recovery supports an overall favorable treatment effect. This suggests anesthesia technique itself constitutes independent determinant of anxiety, with effects extending beyond isolated anxiety scores to encompass meaningful improvements in perioperative recovery. BPB likely attenuates sympathetic arousal through limb-specific neural blockade, avoidance of mask induction and endotracheal intubation, and reinforcement of perceived control. Biologically, dense peripheral analgesia reduces nociceptive input, lowering opioid requirements and secondarily postoperative nausea and vomiting risk. Shorter post-anesthesia care unit length of stay and higher quality of recovery-15 indicate physiologic benefits translate into clinically meaningful/operationally relevant improvements. Exploratory associations between anxiety improvement and better recovery (less pain/opioid use, higher quality of recovery-15) were modest but directionally consistent, supporting anxiety as modifiable proximal target in perioperative pathway.\u003c/p\u003e\n\u003cp\u003eExisting comparative studies emphasize BPB advantages in analgesia, opioid sparing, and postoperative nausea and vomiting reduction, while anxiety frequently treated as secondary/unmeasured endpoint with heterogeneous co-interventions (education, sedation) (3,4). Present trial standardization of education content/sedation targets, fixed measurement time-points, and blinded outcome assessors/statisticians isolates anesthetic modality contribution more convincingly. Convergence of effects across psychological, nociceptive, antiemetic, and throughput outcomes extends prior work showing reduced preoperative anxiety co-occurs with expected downstream clinical gains when care processes harmonized.\u003c/p\u003e\n\u003cp\u003eKey strengths include rigorous randomization with allocation concealment (11); harmonization of co-interventions (education module, sedation targets, multimodal analgesia, postoperative nausea and vomiting prophylaxis); blinded assessment and analysis (11); fidelity safeguards for regional anesthesia (experienced operators with \u0026ge;50 documented blocks, procedure checklists, ultrasound image capture). Block success rate (92%) and conversion frequency (8%) align with contemporary expert center benchmarks (14,17,19,20); community practice rates may vary with operator experience and institutional volume.\u003c/p\u003e\n\u003cp\u003eLimitations\u003c/p\u003e\n\u003cp\u003eProvider blinding infeasible; performance bias potential cannot entirely excluded, although assessor/statistician blinding and protocol standardization mitigate risk (11). Five patients requiring conversion from BPB to GA had T2 anxiety assessed before conversion decision, minimizing contamination of primary endpoint; per-protocol sensitivity analysis confirmed consistency of findings. All blocks performed by highly experienced operators (\u0026ge;5 years, \u0026ge;50 infraclavicular blocks); success rates may differ in lower-volume centers or with less experienced practitioners, potentially limiting generalizability. STAI-S was designated as the single primary endpoint, with APAIS-Anxiety serving as a supportive secondary measure for convergent validity. The STAI-S result (p=0.048) approaches the conventional significance threshold, limiting confidence in the finding. Differential timing of T2 anxiety assessment represents a potential confounding factor: BPB patients were assessed after procedural sedation (propofol), whereas GA patients were assessed before any sedation. This reflects the pragmatic nature of anxiety assessment immediately pre-surgery in each technique but may have contributed to observed anxiety differences; however, the directionally consistent APAIS results and robust secondary outcome benefits support the validity of findings beyond isolated sedation effects. Sample size was calculated to detect a moderate effect (Cohen\u0026apos;s d\u0026asymp;0.5) with 80% power. The observed effect size (d\u0026asymp;0.34) was smaller than anticipated, reducing statistical power to approximately 50-60% and yielding a borderline significance level (p=0.048) with wide confidence interval. This limits precision of the estimate and confidence in the finding. Larger studies are needed to confirm the anxiety reduction with adequate precision. Single-center design and 24-hour follow-up limit generalizability, precluding conclusions about longer-term function or chronic pain (23). Low event rates restrict precision of safety estimates for rare complications. Observed correlations between anxiety change and clinical outcomes small; mediation inferences hypothesis-generating.\u003c/p\u003e\n\u003cp\u003eClinical Implications\u003c/p\u003e\n\u003cp\u003eFor eligible American Society of Anesthesiologists I\u0026ndash;II adults, brachial plexus block preferentially offered when expertise/resources permit (3,4). Counseling credibly emphasizes expected benefits\u0026mdash;lower preoperative anxiety (5,6,7), improved analgesia, reduced opioid exposure/postoperative nausea and vomiting, faster post-anesthesia care unit readiness, higher early recovery quality. Short screening tools (State-Trait Anxiety Inventory-State/Amsterdam Preoperative Anxiety and Information Scale) (6,7,8) identify patients deriving maximal benefit from regional-first approach with targeted counseling. Systems perspective: reductions in post-anesthesia care unit length of stay/antiemetic rescue enhance ambulatory throughput/resource utilization.\u003c/p\u003e\n\u003cp\u003eFuture Directions\u003c/p\u003e\n\u003cp\u003eMulticenter trials with extended follow-up needed to evaluate durability, functional outcomes, health-economic impact. Factorial or mechanistic designs test additive value of explicit anxiety-targeted interventions layered onto brachial plexus block. Comparative studies of infraclavicular versus alternative approaches (supraclavicular, axillary) under standardized volumes/concentrations refine efficacy-safety balance. Equity-focused subgroup analyses (sex, age, high-anxiety strata) guide personalization, ensure benefits broadly realized.\u003c/p\u003e\n\u003cp\u003eReporting Note\u003c/p\u003e\n\u003cp\u003eFigures displaying distributions use medians/interquartile ranges (boxplots) unless stated; asterisks denote *p \u0026lt; 0.05, **p \u0026lt; 0.01, ***p \u0026lt; 0.001 from adjusted models.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eWithin modern standardized perioperative pathway, brachial plexus block was associated with a statistically significant but clinically modest reduction in preoperative anxiety, accompanied by robust multidomain recovery advantages over general anesthesia (5,6,7). Confirmation in diverse settings/longer horizons warranted; present data provide compelling rationale for regional-first strategy in upper-extremity orthopedic surgery when patient preference, clinician expertise, institutional logistics aligned (3,4).\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Institutional Review Board/Ethics Committee of University of Health Sciences Adana City Hospital (approval number: [536], date: [08/05/2025]). The study was conducted in accordance with the Declaration of Helsinki, International Council for Harmonisation-Good Clinical Practice guidelines, and all applicable national regulations. Written informed consent was obtained from all participants prior to enrollment. All participants were informed of their right to withdraw from the study at any time without prejudice to their care.\u003c/p\u003e\n\u003cp\u003eConsent for publication\u003c/p\u003e\n\u003cp\u003eNot applicable. This manuscript does not contain any individual person\u0026apos;s data in any form (including individual details, images, or videos).\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request. Individual participant data cannot be made publicly available due to ethical and privacy considerations, as it could compromise participant confidentiality. De-identified data supporting the findings of this study will be shared with qualified researchers for legitimate scientific purposes following approval by the institutional data access committee and execution of appropriate data sharing agreements.\u003c/p\u003e\n\u003cp\u003eCompeting interests\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests related to this work. No author has financial or non-financial interests that could inappropriately influence or bias the content of this manuscript.\u003c/p\u003e\n\u003cp\u003eFunding\u003c/p\u003e\n\u003cp\u003eThis study was not funded\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAuthors\u0026apos; contributions\u003c/p\u003e\n\u003cp\u003eDU (Dilek Ucak) conceived and designed the study, obtained ethical approval, coordinated patient recruitment, performed data analysis, and drafted the manuscript. [Hatice Şimşek \u0026Uuml;lk\u0026uuml;] contributed to study design, performed regional anesthesia procedures, and critically revised the manuscript. [\u0026Ccedil;ağla Bali and Osman \u0026Ccedil;iloğlu] contributed to data collection, statistical analysis, and manuscript revision. . All authors read and approved the final manuscript and agree to be accountable for all aspects of the work.\u003c/p\u003e\n\u003cp\u003eTrial Registration\u003c/p\u003e\n\u003cp\u003eThis trial was not prospectively registered prior to patient enrollment. The authors acknowledge this limitation and understand that BMC Anesthesiology\u0026apos;s editorial policy requires clinical trial registration. We are prepared to retrospectively register this trial in an appropriate public registry (such as ClinicalTrials.gov or a WHO Primary Registry Platform) should the manuscript be considered favorably for publication, and will provide the trial registration number upon completion of registration.\u003c/p\u003e"},{"header":"References","content":"\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003eGan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, et al. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020;131(2):411-448.\u003c/li\u003e\n \u003cli\u003eHadzic A, Arliss J, Kerimoglu B, Karaca PE, Yufa M, Claudio RE, et al. A comparison of infraclavicular nerve block versus general anesthesia for hand and wrist day-case surgeries. Anesthesiology. 2004;101(1):127-132.\u003c/li\u003e\n \u003cli\u003eLiu SS, Strodtbeck WM, Richman JM, Wu CL. A comparison of regional versus general anesthesia for ambulatory anesthesia: a meta-analysis of randomized controlled trials. Anesth Analg. 2005;101(6):1634-1642.\u003c/li\u003e\n \u003cli\u003eElia N, Lysakowski C, Tramer MR. Does multimodal analgesia with acetaminophen, NSAIDs, or COX-2 inhibitors and morphine improve postoperative pain? A meta-analysis. Anesth Analg. 2005;100(5):1365-1374.\u003c/li\u003e\n \u003cli\u003eShebl A, Kovoor JG, Siddiqui N, Jinatongthai P, Orhurhu VJ. Preoperative anxiety in adult surgical patients: a systematic review and meta-analysis. J Clin Transl Sci. 2025;9:e20.\u003c/li\u003e\n \u003cli\u003eSpielberger CD, Gorsuch RL, Lushene R, Vagg PR, Jacobs GA. Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1983.\u003c/li\u003e\n \u003cli\u003eJulian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011;63 Suppl 11(0 11):S467-S472.\u003c/li\u003e\n \u003cli\u003eMoerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996;82(3):445-451.\u003c/li\u003e\n \u003cli\u003eMcRae K, Leddy JJ, Chan VW, et al. The effect of preoperative anxiolysis with midazolam on preoperative anxiety and postoperative pain. Reg Anesth Pain Med. 2001;26(4):352-356.\u003c/li\u003e\n \u003cli\u003eMaurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013;11:166.\u003c/li\u003e\n \u003cli\u003eSchulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.\u003c/li\u003e\n \u003cli\u003eChan AW, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. BMJ. 2013;346:e7586.\u003c/li\u003e\n \u003cli\u003eStark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013;118(6):1332-1340.\u003c/li\u003e\n \u003cli\u003eGauss A, Tugtekin I, Georgieff M, Dinse-Lambracht A, Keipke D, Gorsewski G. Incidence of clinically symptomatic pneumothorax in ultrasound-guided infraclavicular and supraclavicular brachial plexus block. Anaesthesia. 2014;69(4):327-336.\u003c/li\u003e\n \u003cli\u003eSites BD, Beach M, Gallagher JD, Jarrett RA, Sparks MB, Lundberg CJ. A single injection ultrasound-assisted femoral nerve block provides side effect-sparing analgesia when compared with intrathecal morphine in patients undergoing total knee arthroplasty. Anesth Analg. 2004;99(5):1539-1543.\u003c/li\u003e\n \u003cli\u003eSessler CN, Gosnell MS, Grap MJ, Brophy GM, O\u0026apos;Neal PV, Keane KA, et al. The Richmond Agitation-Sedation Scale: validity and reliability in adult ICU patients. Crit Care Med. 2002;30(5):1190-1196.\u003c/li\u003e\n \u003cli\u003eWong SS, Irwin MG, Yan SY, Hui TW, Mak PH, Chan MT. Infraclavicular brachial block versus general anaesthesia for distal radius fixation: a randomised trial. BMC Anesthesiol. 2020;20(1):156.\u003c/li\u003e\n \u003cli\u003eAldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995;7(1):89-91.\u003c/li\u003e\n \u003cli\u003eNeal JM, Woodward CM, Harrison TK. The American Society of Regional Anesthesia and Pain Medicine Checklist for Managing Local Anesthetic Systemic Toxicity: 2017 version. Reg Anesth Pain Med. 2018;43(2):150-153.\u003c/li\u003e\n \u003cli\u003eBrull R, McCartney CJ, Chan VW, El-Beheiry H. Neurological complications after regional anesthesia: contemporary estimates and a meta-analysis of risk. Anesth Analg. 2007;104(4):965-974.\u003c/li\u003e\n \u003cli\u003eWhite IR, Royston P, Wood AM. Multiple imputation using chained equations: issues and guidance for practice. Stat Med. 2011;30(4):377-399.\u003c/li\u003e\n \u003cli\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)\u0026mdash;a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-381.\u003c/li\u003e\n \u003cli\u003eDroog R, Kappen TH, Rozemeijer W, Kalkman CJ, van Klei WA. Long-term postoperative pain after regional versus general anesthesia: a systematic review and meta-analysis. Anesth Analg. 2023;137(4):e63-e74.\u003c/li\u003e\n \u003cli\u003eCorsaletti BF, Proen\u0026ccedil;a MG, Bisca GW, Leite JC, Bellinetti LM, Pitta F. Minimal important difference for anxiety and depression surveys after physical training program in COPD patients. Fisioter Mov. 2014;27(4):589-598.\u003c/li\u003e\n \u003cli\u003ePlummer F, Manea L, Trepel D, McMillan D. Screening for anxiety disorders with the GAD-7 and GAD-2: a systematic review and diagnostic metaanalysis. Gen Hosp Psychiatry. 2016;39:24-31.\u003c/li\u003e\n \u003cli\u003eLi G, Taljaard M, Van den Heuvel ER, Levine MA, Cook DJ, Wells GA, Devereaux PJ, Thabane L. An introduction to multiplicity issues in clinical trials: the what, why, when and how. Int J Epidemiol. 2017;46(2):746-755.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1. Baseline Characteristics (Intention-to-Treat)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eCharacteristic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eBPB (n=60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eGA (n=60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eStd. Diff\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eAge, years (mean \u0026plusmn; SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e43.13 \u0026plusmn; 10.49\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e41.15 \u0026plusmn; 9.72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e+0.20\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eSTAI-S at T0 (mean \u0026plusmn; SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e40.45 \u0026plusmn; 8.75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e41.98 \u0026plusmn; 7.41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e-0.19\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eFemale sex, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e28 (46.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e30 (50.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e-0.07\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eASA II, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e24 (40.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e25 (41.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e-0.03\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eSurgical region \u0026ndash; Distal, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e42 (70.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e41 (68.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e+0.04\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003eSurgical region \u0026ndash; Proximal, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e18 (30.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e19 (31.7%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 144px;\"\u003e\n \u003cp\u003e-0.04\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eStd. Diff = standardized difference (absolute |value| \u0026ge; 0.10 suggests imbalance).\u003c/p\u003e\n\u003cp\u003eTable 2. Primary and Secondary Outcomes (Adjusted Analyses)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eOutcome\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eBPB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eGA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eEffect (95% CI)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eModel / Effect\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003ep\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003ePreoperative anxiety at T2 \u0026ndash; STAI-S\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e34.32 (SD 8.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e37.35 (SD 9.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdj. MD \u0026minus;3.03 (\u0026minus;6.04 to \u0026minus;0.02)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eANCOVA (STAI-S T0, sex, region)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e0.048\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003ePreoperative anxiety at T2 \u0026ndash; APAIS-Anxiety\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e7.75 (SD 2.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e8.93 (SD 2.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdj. MD \u0026minus;1.12 (\u0026minus;1.95 to \u0026minus;0.29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eANCOVA (supportive)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e0.009\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003ePain NRS \u0026ndash; PACU\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e3.78 (SD 2.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e5.36 (SD 2.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdj. MD \u0026minus;1.43 (\u0026minus;2.10 to \u0026minus;0.76)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eLMM (timepoint-specific)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003ePain NRS \u0026ndash; 24 h\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e2.57 (SD 1.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e4.04 (SD 2.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdj. MD \u0026minus;1.22 (\u0026minus;1.92 to \u0026minus;0.52)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eLMM (timepoint-specific)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eOpioid consumption 0\u0026ndash;24 h (MME)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e7.65 (SD 5.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e15.43 (SD 8.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eMean ratio 0.52 (0.39\u0026ndash;0.70)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eGLM (Gamma, log-link)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003ePONV within 24 h\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e11/60 (18.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e23/60 (38.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdj. OR 0.36 (0.16\u0026ndash;0.83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eLogistic regression (sex, MME)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e0.025\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003ePACU length of stay, min\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003emedian 64.3 (IQR 52\u0026ndash;78)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003emedian 82.6 (IQR 68\u0026ndash;96)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eMedian diff \u0026minus;18.3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eQuantile regression (median)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eQuality of recovery at 24 h \u0026ndash; QoR-15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e130.2 (SD 12.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e120.3 (SD 14.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdj. MD 9.92 (5.37\u0026ndash;14.48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdjusted linear model\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e\u0026lt;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003ePatient satisfaction (5-point) at 24 h\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e4.23 (SD 0.71)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e3.86 (SD 0.69)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdj. MD 0.37 (0.12\u0026ndash;0.62)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003eAdjusted linear model\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 96px;\"\u003e\n \u003cp\u003e0.004\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAbbreviations: Adj., adjusted; MD, mean difference; OR, odds ratio; LMM, linear mixed model; GLM, generalized linear model; IQR, interquartile range; MME, oral morphine milligram equivalents; PONV, postoperative nausea/vomiting.\u003c/p\u003e\n\u003cp\u003eTable 3. Adverse Events and Protocol Deviations\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eEvent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eBPB (n=60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eGA (n=60)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eConversion to GA (BPB arm only)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e5 (8.3%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eLocal anesthetic systemic toxicity (LAST)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003ePneumothorax\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eNeurologic symptoms \u0026gt;48 h\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e6 (10.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eAirway events\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e0 (0.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e3 (5.0%)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eData shown as n (%). Events were prospectively defined; all patients were followed to 24 h, with additional contact if symptoms persisted.\u0026nbsp;\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Brachial plexus block, General anesthesia, Preoperative anxiety, Regional anesthesia, Upper extremity surgery, Perioperative outcomes, Quality of recovery, Randomized controlled trial","lastPublishedDoi":"10.21203/rs.3.rs-8465510/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8465510/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003ePreoperative anxiety is common in surgical patients and associated with adverse perioperative outcomes. While ultrasound-guided brachial plexus block (BPB) provides effective analgesia for upper-extremity surgery, its isolated effect on preoperative anxiety compared with general anesthesia (GA) remains underexplored. This randomized controlled trial compared BPB with GA for their effects on preoperative anxiety and postoperative recovery in adults undergoing elective upper-extremity orthopedic surgery.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eWe conducted a prospective, randomized, parallel-group superiority trial at a tertiary academic hospital. Adults aged 18–65 years with ASA physical status I–II undergoing elective upper-extremity orthopedic procedures were randomized 1:1 to ultrasound-guided infraclavicular BPB or GA. All participants received standardized preoperative education and harmonized perioperative care. Primary endpoint was preoperative anxiety immediately prior to operating room entry measured using State-Trait Anxiety Inventory-State (STAI-S). Secondary endpoints included pain scores, opioid consumption, postoperative nausea and vomiting (PONV), post-anesthesia care unit (PACU) length of stay, quality of recovery-15 (QoR-15), and patient satisfaction.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003e120 patients were randomized (60 per group) with 0% loss to follow-up. BPB reduced preoperative anxiety compared with GA (STAI-S: adjusted mean difference −3.03, 95% CI: −6.04 to −0.02, p=0.048). BPB also demonstrated superior outcomes in early pain reduction (adjusted MD −1.43, p\u0026lt;0.001), opioid consumption (mean ratio 0.52, p\u0026lt;0.001), PONV incidence (adjusted OR 0.36, p=0.025), PACU length of stay (median difference −18.3 min, p\u0026lt;0.001), QoR-15 scores (adjusted MD 9.92, p\u0026lt;0.001), and patient satisfaction (adjusted MD 0.37, p=0.004). Five patients (8%) in the BPB arm required conversion to GA. No serious adverse events occurred.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eWithin a standardized perioperative pathway, brachial plexus block was associated with a statistically significant but clinically modest reduction in preoperative anxiety, accompanied by robust multidomain recovery advantages over general anesthesia. The clinical significance of the isolated anxiety reduction remains uncertain; however, the constellation of benefits across pain, opioid consumption, PONV, and quality of recovery supports an overall favorable treatment effect for regional anesthesia in upper-extremity orthopedic surgery.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration: \u003c/strong\u003eClinicalTrials.gov NCT07352839. Retrospectively registered on January 13, 2026.\u003c/p\u003e","manuscriptTitle":"Brachial Plexus Block Versus General Anesthesia for Upper-Extremity Orthopedic Surgery: Effect on Preoperative Anxiety and Recovery Outcomes – A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-13 11:49:53","doi":"10.21203/rs.3.rs-8465510/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"d1c969fa-6c9d-4f26-9dd7-eb5124db3289","owner":[],"postedDate":"February 13th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-16T13:54:57+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-13 11:49:53","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8465510","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8465510","identity":"rs-8465510","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}