Clavipectoral fascia block associated with intermediate cervical plexus block versus intermediate cervical plexus block alone in clavicle surgeries: a randomized clinical trial

Clavipectoral fascia block associated with intermediate cervical plexus block versus intermediate cervical plexus block alone in clavicle surgeries: a randomized clinical 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 Clavipectoral fascia block associated with intermediate cervical plexus block versus intermediate cervical plexus block alone in clavicle surgeries: a randomized clinical trial Diogo Conceicao, Pablo Helayel, Jorge Garcia, Joaquim Edson Vieira This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5327123/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 13 You are reading this latest preprint version Abstract Background: Midshaft clavicular fractures account for approximately 5% of bone fractures. Surgical correction is often necessary to ensure adequate functional recovery. There is no consensus in the literature on which Regional Anesthesia method should be used to provide appropriate postoperative analgesia. The aim of this study was to evaluate the quality of immediate postoperative analgesia by recording morphine consumption and time spent in the post-anesthesia care unit, following clavipectoral fascia block associated with intermediate cervical plexus block compared to intermediate cervical plexus block alone, in surgical operations for fracture synthesis after midshaft clavicle fracture. Methods: Forty patients undergoing surgical operations for midshaft clavicle fracture correction were randomly allocated into two groups: intermediate cervical plexus block associated with clavipectoral fascia block (Group I) and intermediate cervical plexus block alone (Group C). After applying the inclusion and exclusion criteria, and under general anesthesia, the patients received one of the described blocks. Data were blinded for analysis, and a significance level of 5% was considered. Results: The median (IQR) morphine consumption in the PACU for Group I was 0 (0-0) mg compared to 0 (0-3) mg for Group C (p=0.149). The median (IQR) PACU stay time for Group I was 60 (60-82.5) minutes compared to 75 (60-90) minutes for Group C (p=0.174). Conclusion: Under the conditions of this study, the clavipectoral fascia block, whether associated with or without the intermediate cervical plexus block, did not result in significant differences between the groups in terms of immediate postoperative morphine consumption or PACU stay time. Trial Registration: The study was registered with the Brazilian Registry of Clinical Trials (ReBEC) under number U1111-1255-2364. Analgesia Morphine Cervical plexus Clavicle Regional anesthesia Fractures bone Figures Figure 1 INTRODUCTION Clavicle fractures are prevalent injuries, particularly among young and active individuals, often resulting from direct trauma, such as motor vehicle accidents or falls during sports activities. These fractures account for approximately 5% of all bone fractures seen in orthopedic practice, with around 70% occurring in the middle third of the clavicle, a structurally vulnerable region due to its anatomical position.(1) The management of clavicle fractures has significantly advanced over the past decades. Conservative treatment is generally preferred for non-displaced or minimally displaced fractures. However, surgical intervention is now recommended for displaced or unstable fractures. The increased frequency of surgical procedures has led to a growing demand for effective anesthetic techniques that provide sufficient analgesia while minimizing intraoperative and postoperative complications.(2) In recent years, the trend toward performing clavicle fracture surgeries in outpatient settings, to reduce healthcare costs while maintaining surgical outcomes and patient satisfaction, has posed additional challenges.(3) Selecting the most appropriate anesthetic approach becomes crucial, especially considering the complex innervation of the clavicle, which involves contributions from both the cervical and brachial plexus. The complexity of clavicle innervation has been extensively discussed in the literature. Tran et al.(4) highlighted the variability in the description of its innervation, noting general agreement that the skin overlying the clavicle is primarily innervated by the supraclavicular nerve, which originates from the superficial cervical plexus. However, consensus is lacking regarding the innervation of the clavicle bone itself. Several nerves, including the supraclavicular, subclavian, suprascapular, and long thoracic nerves, have been identified as contributors, though their roles vary across studies. More recent investigations have provided further insights into clavicle innervation. Leurcharusmee et al.(5) performed cadaveric dissections that demonstrated the involvement of the supraclavicular nerve, the subclavian nerve, and the lateral pectoral nerve in innervating the clavicle, with the supraclavicular nerve being the primary nerve responsible for the middle third of the clavicle. Various regional anesthesia techniques have been proposed to provide adequate analgesia for patients undergoing clavicle surgery. Due to the need for patients to be positioned in a beach chair or semi-beach chair posture during the procedure and the importance of ensuring a protected airway, general anesthesia combined with regional analgesia remains the most widely used approach. Techniques such as the superficial cervical plexus block, the interscalene brachial plexus block, and the clavipectoral fascia block have all been explored. Yet, no clear consensus exists on the optimal method for providing analgesia in these cases. (6, 7) While the interscalene brachial plexus block is a commonly employed technique, it is associated with potential side effects, such as ipsilateral phrenic nerve block, temporary upper limb paralysis, Horner's syndrome, and the risk of nerve injury. These complications can be reduced or avoided by employing more targeted techniques focusing on the surgical area's sensory innervation. The clavipectoral fascia block, introduced by Valdés-Vilches(8), is a novel regional anesthesia technique designed to provide analgesia for surgeries involving the middle third of the clavicle. The clavipectoral fascia, a dense layer of connective tissue located deep to the pectoralis major muscle, envelops the clavicle and its nerve endings, making it an effective target for regional anesthesia. Labandeyra et al.(9) further investigated this technique by examining the distribution of methylene blue following the clavipectoral fascia block in cadaver models of middle-third clavicle fractures. Their findings indicated that the anesthetic solution predominantly spread over the clavicle's anterosuperior region, suggesting this block's potential efficacy when the clavicular periosteum is disrupted. The intermediate cervical plexus block, introduced in 2004 (10), represents another technique that has gained attention for its application in clavicle surgeries. This block targets the interfacial space between the sternocleidomastoid and prevertebral muscles, which can be difficult to access without ultrasound guidance. Studies suggest that this block provides anesthetic effects comparable to the deep cervical block while minimizing complications such as phrenic nerve paralysis(10). The advent of ultrasound technology has enhanced the precision and safety of this technique, making it a promising option for head, neck, and clavicle surgeries, particularly in the context of reducing adverse effects associated with deeper or more invasive techniques(11). The primary objective of this study was to evaluate the quality of immediate postoperative analgesia by measuring morphine consumption in the post-anesthesia care unit (PACU). This study compared two anesthetic techniques: the combination of the clavipectoral fascia block with the intermediate cervical plexus block versus the intermediate cervical plexus block alone in outpatient surgical fixation of middle third clavicle fractures under general intravenous anesthesia. The secondary objective was to assess the duration of the patient's stay in the PACU. METHODS This prospective, randomized, double-blind study was conducted between August 2020 and November 2021 following approval from the Institutional Research Ethics Committee at Hospital Governador Celso Ramos (approval number 4.365.270). The study was also registered with the Brazilian Registry of Clinical Trials (ReBEC) under number U1111-1255-2364. All participants provided signed informed consent. The study adhered to the CONSORT guidelines to ensure proper research reporting. Inclusion criteria included patients aged 18 to 65 with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III and a body mass index (BMI) between 18 and 35 kg/m². Exclusion criteria included refusal to participate or sign the informed consent form, chronic opioid use, pre-existing neurological deficits, allergies to study medications, or signs of infection at the intervention site. A total of 40 patients were randomized using a block randomization method with a 1:1 allocation ratio between the intervention group (I) and control group (C). The randomization sequence was generated by specialized software (www.randomizer.org) and concealed in opaque, sealed, and sequentially numbered envelopes. These envelopes were opened only when a patient was enrolled, ensuring that both the researchers and participants remained blinded to the group assignments. Patients scheduled for outpatient surgical fixation of middle-third clavicle fractures were invited to participate. After receiving detailed information about the study protocol, including perioperative procedures, postoperative analgesia management, and the evaluation process, patients who provided informed consent were randomly assigned to either group I or group C, as previously described. Postoperative data were analyzed by a blinded researcher who was unaware of the patient group allocation and followed the patient throughout their stay in the post-anesthesia care unit (PACU). Due to the nature of the procedures, the researchers administering the blocks were not blinded. Simulated blocks were not performed to avoid unnecessary risks to the patients. All patients in both groups received total intravenous general anesthesia before the regional anesthesia techniques were performed. No medium- or long-acting opioids were administered during the operative period. Patients were not premedicated before anesthesia induction. General anesthesia was induced using target-controlled infusion (TCI) of propofol at a concentration of 4 µg.mL⁻¹, with maintenance at 3 to 4 µg.mL⁻¹. Remifentanil was continuously infused at 0.1 to 0.2 µg.kg⁻¹.min⁻¹, according to the anesthesiologist's discretion. Atracurium was administered intravenously in a bolus of 0.5 mg. kg⁻¹ to facilitate endotracheal intubation. Adjunct medications included 4 mg of dexamethasone, 100 mg of ketoprofen, and 1 gram of dipyrone, given after anesthetic induction and prior to performing the regional anesthesia techniques. Ultrasound guidance was used for all blocks, utilizing a 4 cm linear transducer (HFL38x, Sonosite FujiFilm® M-Turbo) and 50 mm 22 G short-beveled needles (Stimuplex A-50, B-Braun). The ultrasound transducer was covered with a sterile transparent dressing (Tegaderm™ 3M™), and the skin at the block site was disinfected with 0.5% alcoholic chlorhexidine solution. Regional anesthesia techniques were performed as follows: Group I (Intervention): Patients received an intermediate cervical plexus block, as described by Tran et al., under ultrasound guidance with 10 mL of 0.5% ropivacaine (Ropi® Cristália Laboratory, Brazil), combined with a clavipectoral fascia block, as described by Valdés-Vilches, using 20 mL of 0.5% ropivacaine (10 mL at the medial-third/middle-third junction and 10 mL at the lateral-third/middle-third junction of the clavicle). Group C (Control): Patients received an intermediate cervical plexus block under ultrasound guidance with 10 mL of 0.5% ropivacaine. Intermediate cervical plexus block procedure: The patient was positioned supine with a cervical rotation of 30 to 45 degrees towards the contralateral side. The ultrasound transducer was placed transversely over the midpoint of the sternocleidomastoid muscle at the cricoid cartilage level. After identifying the sternocleidomastoid muscle and its posterior border, the interscalene groove between the anterior and middle scalene muscles was located. The cervical plexus was visualized superficially to the prevertebral fascia, and a 22 G short-beveled needle was inserted laterally to medially, positioning its tip near the cervical plexus. After negative aspiration, 10 mL of 0.5% ropivacaine was injected. Clavipectoral fascia block procedure: With the patient supine, the ultrasound transducer was placed over the medial-third/middle-third junction of the clavicle. After localizing the clavicle, 10 mL of 0.5% ropivacaine was injected adjacent to the clavicular periosteum. A similar procedure was performed at the lateral-third/middle-third junction. Postoperative pain management: Upon arrival at the PACU, patients were instructed to request analgesics if they experienced pain. Patients were assessed every 10 minutes for pain as a yes or no question. If present, 2 mg of intravenous morphine was administered, with additional doses of 2 mg given every 10 minutes as needed, up to a maximum of 20 mg. No pain was required before PACU discharge. The amount of morphine used and the length of PACU stay were recorded. Other perioperative data, including age, BMI, sex, comorbidities, and symptoms such as dyspnea or Horner’s syndrome, were monitored. Chest X-rays would be performed if dyspnea was reported to investigate phrenic nerve paralysis. 3.1 Statistical Analysis and Sample Size Using Fisher's exact test, qualitative variables were compared and reported as frequencies and percentages. The Shapiro-Wilk test was used to assess the normality of quantitative variables. As the variables did not follow a normal distribution, the Mann-Whitney U test was used, with results presented as medians and interquartile ranges (IQR). A p-value of ≤ 0.05 was considered statistically significant. The sample size calculation was based on an expected 20% reduction in morphine consumption in the intervention group. To achieve 80% power and a significance level of 0.05, 19 patients per group were required. Data were analyzed using SPSS for Windows (version 20, IBM Inc., USA). RESULTS Figure 1 shows The CONSORT diagram for the study. Among the patients, 75% were male and 25% were female, but no significant difference was observed in sex distribution between the groups (p>0.05). The mean age and BMI followed a similar pattern (Table 1). Table 1 Demographic data and physical status Features I C p Sex* (M/F) 14(70%)/6 (30%) 16(80%)/4 (20%) 0,71 Age # (years) 32,60 ± 10,27 28,95 ± 10,61 0,28 BMI # (kg/m 2 ) 25,55 ± 5,10 22,90 ± 3,17 0,056 ASA* I / II 11(55%)/9 (45%) 11(55%)/9 (45%) 1,0 *frequency and respective percentages; # mean ± dp. M/F male, female; BMI: body mass index, ASA: American Society of Anesthesiologists . No patients in the sample reported dyspnea or exhibited signs of Horner’s syndrome. The median (IQR) morphine consumption in the PARR was 0 (0–0) mg in the I group compared with 0 (0–3) in the C group (p=0.149). The median (IQR) length of stay in the ARDS was 60 (60–82.5) min in the I group compared with 75 (60–90) min in the C group (p=0.174) (Table 2). Table 2 Morphine consumption in mg and length of stay in PARR I C p Morphine consumption (mg) 0 (0–0) * 0 (0–3) * p=0 ,149 Time in PARR (min) 60(60–82,5)* 75(60–90)* p=0 ,174 * median (IQR) A post-hoc sample size analysis was conducted based on the prevalence of morphine use in the PACU, which was 32.5%. Consequently, the sample of 40 cases demonstrated a statistical power of 0.807 (80.7%) to detect a significant difference. DISCUSSION This study found no statistically significant difference in immediate postoperative morphine consumption between the group that received the clavipectoral fascia block combined with the intermediate cervical plexus block and the group that received only the intermediate cervical plexus block under general intravenous anesthesia. Similarly, there was no significant difference in the duration of stay in the post-anesthesia care unit (PACU). Tran et al.(4) highlighted the variability in the description of clavicle innervation in the literature. Leurcharusmee et al.(5), after analyzing the innervation of 40 clavicles from fresh cadavers, identified the supraclavicular nerve as the primary nerve responsible for innervating the middle third of the clavicle. Our findings align with this, as no difference in morphine consumption was observed between the two groups, suggesting that the supraclavicular nerve, derived from the cervical plexus, plays a critical role not only in the innervation of the skin and subcutaneous tissue over the clavicle but also in the periosteum of the clavicle middle third. Abdelghany et al.(6) also reported no difference in perioperative analgesia between patients receiving only the intermediate cervical plexus block and those receiving a combination of the interscalene brachial plexus block with the cervical plexus block for middle-third clavicle surgeries. Our results corroborate these findings, reinforcing the role of the intermediate cervical plexus block in this clinical scenario. Herring et al.(12) demonstrated the success of ultrasound-guided cervical plexus blocks in providing adequate analgesia for patients with middle-third clavicle fractures in the emergency department. Finlayson et al.(13) further emphasized that ultrasound-guided intermediate cervical plexus blocks were more effective than techniques relying solely on anatomical landmarks for local anesthetic injection. This might explain the similar outcomes observed in our study, where ultrasound guidance was used for all procedures. Zhuo et al.(7) demonstrated a low incidence of diaphragmatic paralysis when combining the clavipectoral fascia block with the intermediate cervical plexus block compared to the interscalene brachial plexus block. In our study, no clinical signs suggestive of phrenic nerve paralysis or Horner’s syndrome were observed. However, it cannot be ruled out that some patients might have experienced subclinical phrenic nerve paralysis, a potential limitation of this study. One significant limitation of our study is that the protocol did not include clinical verification of block efficacy. Since the clavipectoral fascia block is a painful procedure, it was performed under general anesthesia for patient comfort, which prevented clinical assessment of its immediate effectiveness. This limitation should be addressed in future studies. Another limitation was the lack of assessment of analgesia beyond the immediate postoperative period. Previous studies have reported that regional blocks with ropivacaine typically last 12 to 18 hours at the concentration used in this study. For the Clavipectoral block, Sabaa et al.(14) found that analgesia lasted for about 12 hours when using a mixture of 0.5% bupivacaine and 2% lidocaine. Additionally, this study did not include a comparison with a group receiving only general intravenous anesthesia without any regional techniques. Banerjee et al.(15) demonstrated that patients receiving only general anesthesia experienced higher postoperative pain, greater opioid consumption, and longer PACU stays compared to those receiving regional anesthesia in combination with general anesthesia. Future studies should consider including a control group without regional anesthesia to better understand its impact on postoperative outcomes. In conclusion, this study found no statistically significant difference in immediate postoperative morphine consumption between the group that received the clavipectoral fascia block combined with the intermediate cervical plexus block and the group that received only the intermediate cervical plexus block under general intravenous anesthesia. Controlled studies are needed to further evaluate and determine the most effective anesthetic and analgesic techniques for patients undergoing middle-third clavicle fracture surgeries. Declarations Ethics and Trial Registry Section: Human Ethics and Consent: The study received prior approval from the Institutional Research Ethics Committee at Hospital Governador Celso Ramos, with approval number 4.365.270. Additionally, all participants provided signed informed consent. Funding: there was no specific funding allocated for this study. Trial Number: Clinical trial registration number U1111-1255-2364 from the Brazilian Registry of Clinical Trials (ReBEC). Date of Registry: 08/25/2020. The study was retrospectively registered. Consent for publication: Not Applicable Data Availability: The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request. REFERENCES Miao Qin M, Shishun Zhao, PhDa, Wenlai Guo, PhDb, Li Tang, MSa, Hangyu Li, MSa, Xuejie Wang, MSb,, Zhe Zhu P, ∗, Tianwen Sun, PhDc. Open reduction and plate fixation compared with non-surgical treatment for displaced midshaft clavicle fracture A meta-analysis of randomized clinical trials. Medicine (Baltimore). 2019;98(20):9. Wolf S, Chitnis AS, Manoranjith A, Vanderkarr M, Plaza JQ, Gador LV, et al. Surgical treatment, complications, reoperations, and healthcare costs among patients with clavicle fracture in England. Bmc Musculoskel Dis. 2022;23(1). Vajapey SP, Contreras ES, Neviaser AS, Bishop JY, Cvetanovich GL. Outpatient Total Shoulder Arthroplasty: A Systematic Review Evaluating Outcomes and Cost-Effectiveness. JBJS Rev. 2021;9(5). Tran DQ, Tiyaprasertkul W, González AP. Analgesia for clavicular fracture and surgery: a call for evidence. Reg Anesth Pain Med. 2013;38(6):539-43. Leurcharusmee P, Maikong N, Kantakam P, Navic P, Mahakkanukrauh P, Tran Q. Innervation of the clavicle: a cadaveric investigation. Reg Anesth Pain Med. 2021;46(12):1076-9. Abdelghany MS, Ahmed SA, Afandy ME. Superficial cervical plexus block alone or combined with interscalene brachial plexus block in surgery for clavicle fractures: a randomized clinical trial. Minerva Anestesiol. 2021;87(5):523-32. Zhuo Q, Zheng Y, Hu Z, Xiong J, Wu Y, Zheng Y, et al. Ultrasound-Guided Clavipectoral Fascial Plane Block With Intermediate Cervical Plexus Block for Midshaft Clavicular Surgery: A Prospective Randomized Controlled Trial. Anesth Analg. 2022;135(3):633-40. Valdés-Vilches LF, editor Analgesia for clavicular surgery/fractures. In Symposia 01: Postoperative analgesia for Orthopedic upper and lower limb surgery. . Symposium conducted at the 36th Annual European Society of Regional Anaesthesia and Pain Therapy (ESRA) Congress; 2017; Lugano, Switzerland. Labandeyra H, Heredia C, Valdes-Vilches LF, Prats-Galino A, Sala-Blanch X. Clavipectoral fascia plane block in midshaft clavicle fractures: A cadaveric study. J Clin Anesth. 2024;96:111469. Kim HY, Soh EY, Lee J, Kwon SH, Hur M, Min SK, et al. Incidence of hemi-diaphragmatic paresis after ultrasound-guided intermediate cervical plexus block: a prospective observational study. J Anesth. 2020;34(4):483-90. Jin-Soo Kim JSK, Seunguk Bang,, Hyungtae Kim aSYL. Cervical plexus block. Korean Journal of Anesthesiology. 2018;71(4):15. Herring AA, Stone MB, Frenkel O, Chipman A, Nagdev AD. The ultrasound-guided superficial cervical plexus block for anesthesia and analgesia in emergency care settings. Am J Emerg Med. 2012;30(7):1263-7. Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010;35(6):539-43. Abu Sabaa MA, Elbadry AA, El Malla DA. Ultrasound-Guided Clavipectoral Block for Postoperative Analgesia of Clavicular Surgery: A Prospective Randomized Trial. Anesth Pain Med. 2022;12(1):e121267. Banerjee S, Acharya R, Sriramka B. Ultrasound-Guided Inter-scalene Brachial Plexus Block with Superficial Cervical Plexus Block Compared with General Anesthesia in Patients Undergoing Clavicular Surgery: A Comparative Analysis. Anesth Essays Res. 2019;13(1):149-54. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 17 Feb, 2026 Reviewers agreed at journal 14 Feb, 2026 Reviews received at journal 13 Feb, 2026 Reviewers agreed at journal 13 Feb, 2026 Reviewers agreed at journal 31 Jan, 2026 Reviewers agreed at journal 05 Jan, 2026 Reviews received at journal 16 Dec, 2024 Reviewers agreed at journal 13 Dec, 2024 Reviewers invited by journal 05 Dec, 2024 Editor assigned by journal 02 Dec, 2024 Editor invited by journal 12 Nov, 2024 Submission checks completed at journal 12 Nov, 2024 First submitted to journal 12 Nov, 2024 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-5327123","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":531792448,"identity":"6cde98b4-bb1e-4fe7-8181-79ac5b7218a3","order_by":0,"name":"Diogo Conceicao","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAklEQVRIie2QMWuDQBTHnwi6mLiaxX6FC0JDQPpZFOGyRLI6ZMhkhppkjd/CMePJg7oYumZscel4XUKm0juSoYOajB3uBw/evbsfx/8BKBT/ERSlra49E+XKs2iCxxUPQId+hf1RJOHqnjKsdPz6Pry4ExNLdln6s52zYIwnFOz1a6s3QoNO8zryphkNyuyNxvk+gnJfz8Gpj0WbQtB69gYpC4uTRRAMjItTBDhIEyBOfE+xOcIPzsgDitfcfgHUUgxuyrxTkVk0mYXUlJSbLR3nWUNEFmp1ZRm+I3K5MVJhwy9n/8k2w88PnkSuvd60KgLDaR1bHc8lOu+5VCgUCgXALyFabZNR30ZbAAAAAElFTkSuQmCC","orcid":"","institution":"University of Sao Paulo","correspondingAuthor":true,"prefix":"","firstName":"Diogo","middleName":"","lastName":"Conceicao","suffix":""},{"id":531792450,"identity":"de6f5da0-97ad-44d2-81de-bf44d05073b9","order_by":1,"name":"Pablo Helayel","email":"","orcid":"","institution":"Governador Celso Ramos Hospital","correspondingAuthor":false,"prefix":"","firstName":"Pablo","middleName":"","lastName":"Helayel","suffix":""},{"id":531792452,"identity":"8c647fa5-4215-4401-ad1e-a06e71368f88","order_by":2,"name":"Jorge Garcia","email":"","orcid":"","institution":"Governador Celso Ramos Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jorge","middleName":"","lastName":"Garcia","suffix":""},{"id":531792454,"identity":"3ef21c85-9b2c-4214-97cc-ff0914b6b2b2","order_by":3,"name":"Joaquim Edson Vieira","email":"","orcid":"","institution":"University of Sao Paulo","correspondingAuthor":false,"prefix":"","firstName":"Joaquim","middleName":"Edson","lastName":"Vieira","suffix":""}],"badges":[],"createdAt":"2024-10-24 15:38:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5327123/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5327123/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":94844775,"identity":"3c8fce85-9807-4bc6-b208-4a26561ceac1","added_by":"auto","created_at":"2025-10-31 10:05:25","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":47322,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eConsort Flow Diagram\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5327123/v1/f8c2947f217c98a43ad8c941.png"},{"id":94985247,"identity":"92085f45-2c76-4220-86b6-a41d14b90b0d","added_by":"auto","created_at":"2025-11-03 06:57:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":533554,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5327123/v1/61a929fb-42d2-4758-839e-562d654de4eb.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eClavipectoral fascia block associated with intermediate cervical plexus block versus intermediate cervical plexus block alone in clavicle surgeries: a randomized clinical trial\u003c/p\u003e","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eClavicle fractures are prevalent injuries, particularly among young and active individuals, often resulting from direct trauma, such as motor vehicle accidents or falls during sports activities. These fractures account for approximately 5% of all bone fractures seen in orthopedic practice, with around 70% occurring in the middle third of the clavicle, a structurally vulnerable region due to its anatomical position.(1)\u003c/p\u003e\n\u003cp\u003eThe management of clavicle fractures has significantly advanced over the past decades. Conservative treatment is generally preferred for non-displaced or minimally displaced fractures. However, surgical intervention is now recommended for displaced or unstable fractures. The increased frequency of surgical procedures has led to a growing demand for effective anesthetic techniques that provide sufficient analgesia while minimizing intraoperative and postoperative complications.(2)\u003c/p\u003e\n\u003cp\u003eIn recent years, the trend toward performing clavicle fracture surgeries in outpatient settings, to reduce healthcare costs while maintaining surgical outcomes and patient satisfaction, has posed additional challenges.(3) Selecting the most appropriate anesthetic approach becomes crucial, especially considering the complex innervation of the clavicle, which involves contributions from both the cervical and brachial plexus.\u003c/p\u003e\n\u003cp\u003eThe complexity of clavicle innervation has been extensively discussed in the literature. Tran et al.(4) highlighted the variability in the description of its innervation, noting general agreement that the skin overlying the clavicle is primarily innervated by the supraclavicular nerve, which originates from the superficial cervical plexus. However, consensus is lacking regarding the innervation of the clavicle bone itself. Several nerves, including the supraclavicular, subclavian, suprascapular, and long thoracic nerves, have been identified as contributors, though their roles vary across studies.\u003c/p\u003e\n\u003cp\u003eMore recent investigations have provided further insights into clavicle innervation. Leurcharusmee et al.(5) performed cadaveric dissections that demonstrated the involvement of the supraclavicular nerve, the subclavian nerve, and the lateral pectoral nerve in innervating the clavicle, with the supraclavicular nerve being the primary nerve responsible for the middle third of the clavicle.\u003c/p\u003e\n\u003cp\u003eVarious regional anesthesia techniques have been proposed to provide adequate analgesia for patients undergoing clavicle surgery. Due to the need for patients to be positioned in a beach chair or semi-beach chair posture during the procedure and the importance of ensuring a protected airway, general anesthesia combined with regional analgesia remains the most widely used approach. Techniques such as the superficial cervical plexus block, the interscalene brachial plexus block, and the clavipectoral fascia block have all been explored. Yet, no clear consensus exists on the optimal method for providing analgesia in these cases. (6, 7)\u003c/p\u003e\n\u003cp\u003eWhile the interscalene brachial plexus block is a commonly employed technique, it is associated with potential side effects, such as ipsilateral phrenic nerve block, temporary upper limb paralysis, Horner's syndrome, and the risk of nerve injury. These complications can be reduced or avoided by employing more targeted techniques focusing on the surgical area's sensory innervation.\u003c/p\u003e\n\u003cp\u003eThe clavipectoral fascia block, introduced by Valdés-Vilches(8), is a novel regional anesthesia technique designed to provide analgesia for surgeries involving the middle third of the clavicle. The clavipectoral fascia, a dense layer of connective tissue located deep to the pectoralis major muscle, envelops the clavicle and its nerve endings, making it an effective target for regional anesthesia.\u003c/p\u003e\n\u003cp\u003eLabandeyra et al.(9) further investigated this technique by examining the distribution of methylene blue following the clavipectoral fascia block in cadaver models of middle-third clavicle fractures. Their findings indicated that the anesthetic solution predominantly spread over the clavicle's anterosuperior region, suggesting this block's potential efficacy when the clavicular periosteum is disrupted.\u003c/p\u003e\n\u003cp\u003eThe intermediate cervical plexus block, introduced in 2004\u0026nbsp;(10),\u0026nbsp;represents another technique that has gained attention for its application in clavicle surgeries. This block targets the interfacial space between the sternocleidomastoid and prevertebral muscles, which can be difficult to access without ultrasound guidance. Studies suggest that this block provides anesthetic effects comparable to the deep cervical block while minimizing complications such as phrenic nerve paralysis(10). The advent of ultrasound technology has enhanced the precision and safety of this technique, making it a promising option for head, neck, and clavicle surgeries, particularly in the context of reducing adverse effects associated with deeper or more invasive techniques(11).\u003c/p\u003e\n\u003cp\u003eThe primary objective of this study was to evaluate the quality of immediate postoperative analgesia by measuring morphine consumption in the post-anesthesia care unit (PACU). This study compared two anesthetic techniques: the combination of the clavipectoral fascia block with the intermediate cervical plexus block versus the intermediate cervical plexus block alone in outpatient surgical fixation of middle third clavicle fractures under general intravenous anesthesia. The secondary objective was to assess the duration of the patient's stay in the PACU.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eThis prospective, randomized, double-blind study was conducted between August 2020 and November 2021 following approval from the Institutional Research Ethics Committee at Hospital Governador Celso Ramos (approval number 4.365.270). The study was also registered with the Brazilian Registry of Clinical Trials (ReBEC) under number U1111-1255-2364. All participants provided signed informed consent. The study adhered to the CONSORT guidelines to ensure proper research reporting.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria\u003c/strong\u003e included patients aged 18 to 65 with an American Society of Anesthesiologists (ASA) physical status classification of I, II, or III and a body mass index (BMI) between 18 and 35 kg/m\u0026sup2;. \u003cstrong\u003eExclusion criteria\u003c/strong\u003e included refusal to participate or sign the informed consent form, chronic opioid use, pre-existing neurological deficits, allergies to study medications, or signs of infection at the intervention site.\u003c/p\u003e\n\u003cp\u003eA total of 40 patients were randomized using a block randomization method with a 1:1 allocation ratio between the intervention group (I) and control group (C). The randomization sequence was generated by specialized software (www.randomizer.org) and concealed in opaque, sealed, and sequentially numbered envelopes. These envelopes were opened only when a patient was enrolled, ensuring that both the researchers and participants remained blinded to the group assignments.\u003c/p\u003e\n\u003cp\u003ePatients scheduled for outpatient surgical fixation of middle-third clavicle fractures were invited to participate. After receiving detailed information about the study protocol, including perioperative procedures, postoperative analgesia management, and the evaluation process, patients who provided informed consent were randomly assigned to either group I or group C, as previously described.\u003c/p\u003e\n\u003cp\u003ePostoperative data were analyzed by a blinded researcher who was unaware of the patient group allocation and followed the patient throughout their stay in the post-anesthesia care unit (PACU). Due to the nature of the procedures, the researchers administering the blocks were not blinded. Simulated blocks were not performed to avoid unnecessary risks to the patients.\u003c/p\u003e\n\u003cp\u003eAll patients in both groups received total intravenous general anesthesia before the regional anesthesia techniques were performed. No medium- or long-acting opioids were administered during the operative period. Patients were not premedicated before anesthesia induction. General anesthesia was induced using target-controlled infusion (TCI) of propofol at a concentration of 4 \u0026micro;g.mL⁻\u0026sup1;, with maintenance at 3 to 4 \u0026micro;g.mL⁻\u0026sup1;. Remifentanil was continuously infused at 0.1 to 0.2 \u0026micro;g.kg⁻\u0026sup1;.min⁻\u0026sup1;, according to the anesthesiologist\u0026apos;s discretion. Atracurium was administered intravenously in a bolus of 0.5 mg.\u0026nbsp;kg⁻\u0026sup1; to facilitate endotracheal intubation. Adjunct medications included 4 mg of dexamethasone, 100 mg of ketoprofen, and 1 gram of dipyrone, given after anesthetic induction and prior to performing the regional anesthesia techniques.\u003c/p\u003e\n\u003cp\u003eUltrasound guidance was used for all blocks, utilizing a 4 cm linear transducer (HFL38x, Sonosite FujiFilm\u0026reg; M-Turbo) and 50 mm 22 G short-beveled needles (Stimuplex A-50, B-Braun). The ultrasound transducer was covered with a sterile transparent dressing (Tegaderm\u0026trade; 3M\u0026trade;), and the skin at the block site was disinfected with 0.5% alcoholic chlorhexidine solution.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegional anesthesia techniques\u003c/strong\u003e were performed as follows:\u003c/p\u003e\n\u003cul type=\"disc\"\u003e\n \u003cli\u003e\u003cstrong\u003eGroup I (Intervention):\u003c/strong\u003e Patients received an intermediate cervical plexus block, as described by Tran et al., under ultrasound guidance with 10 mL of 0.5% ropivacaine (Ropi\u0026reg; Crist\u0026aacute;lia Laboratory, Brazil), combined with a clavipectoral fascia block, as described by Vald\u0026eacute;s-Vilches, using 20 mL of 0.5% ropivacaine (10 mL at the medial-third/middle-third junction and 10 mL at the lateral-third/middle-third junction of the clavicle).\u003c/li\u003e\n \u003cli\u003e\u003cstrong\u003eGroup C (Control):\u003c/strong\u003e Patients received an intermediate cervical plexus block under ultrasound guidance with 10 mL of 0.5% ropivacaine.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eIntermediate cervical plexus block procedure:\u003c/strong\u003e The patient was positioned supine with a cervical rotation of 30 to 45 degrees towards the contralateral side. The ultrasound transducer was placed transversely over the midpoint of the sternocleidomastoid muscle at the cricoid cartilage level. After identifying the sternocleidomastoid muscle and its posterior border, the interscalene groove between the anterior and middle scalene muscles was located. The cervical plexus was visualized superficially to the prevertebral fascia, and a 22 G short-beveled needle was inserted laterally to medially, positioning its tip near the cervical plexus. After negative aspiration, 10 mL of 0.5% ropivacaine was injected.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClavipectoral fascia block procedure:\u003c/strong\u003e With the patient supine, the ultrasound transducer was placed over the medial-third/middle-third junction of the clavicle. After localizing the clavicle, 10 mL of 0.5% ropivacaine was injected adjacent to the clavicular periosteum. A similar procedure was performed at the lateral-third/middle-third junction.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePostoperative pain management:\u003c/strong\u003e Upon arrival at the PACU, patients were instructed to request analgesics if they experienced pain. Patients were assessed every 10 minutes for pain as a yes or no question. If present, 2 mg of intravenous morphine was administered, with additional doses of 2 mg given every 10 minutes as needed, up to a maximum of 20 mg. No pain was required before PACU discharge. The amount of morphine used and the length of PACU stay were recorded. Other perioperative data, including age, BMI, sex, comorbidities, and symptoms such as dyspnea or Horner\u0026rsquo;s syndrome, were monitored. Chest X-rays would be performed if dyspnea was reported to investigate phrenic nerve paralysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.1 Statistical Analysis and Sample Size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eUsing Fisher\u0026apos;s exact test, qualitative variables were compared and reported as frequencies and percentages. The Shapiro-Wilk test was used to assess the normality of quantitative variables. As the variables did not follow a normal distribution, the Mann-Whitney U test was used, with results presented as medians and interquartile ranges (IQR). A p-value of \u0026le; 0.05 was considered statistically significant.\u003c/p\u003e\n\u003cp\u003eThe sample size calculation was based on an expected 20% reduction in morphine consumption in the intervention group. To achieve 80% power and a significance level of 0.05, 19 patients per group were required. \u0026nbsp;Data were analyzed using SPSS for Windows (version 20, IBM Inc., USA).\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eFigure 1 shows The CONSORT diagram for the study. Among the patients, 75% were male and 25% were female, but no significant difference was observed in sex distribution between the groups (p\u0026gt;0.05). The mean age and BMI followed a similar pattern (Table 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e1\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; Demographic data and physical status\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"100%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFeatures\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31px;\"\u003e\n \u003cp\u003eSex* (M/F)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e14(70%)/6 (30%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e16(80%)/4 (20%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e0,71\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31px;\"\u003e\n \u003cp\u003eAge\u003csup\u003e#\u003c/sup\u003e (years)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e32,60 \u0026plusmn; 10,27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e28,95 \u0026plusmn; 10,61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e0,28\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31px;\"\u003e\n \u003cp\u003eBMI\u003csup\u003e#\u0026nbsp;\u003c/sup\u003e(kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e25,55 \u0026plusmn; 5,10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e22,90 \u0026plusmn; 3,17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e0,056\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31px;\"\u003e\n \u003cp\u003eASA* I / II\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e11(55%)/9 (45%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e11(55%)/9 (45%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e1,0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"4\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e*frequency and respective percentages;\u003csup\u003e#\u0026nbsp;\u003c/sup\u003emean \u0026plusmn; dp.\u003c/p\u003e\n \u003cp\u003eM/F male, female; BMI: body mass index, ASA: \u003cem\u003eAmerican Society of Anesthesiologists\u003c/em\u003e.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eNo patients in the sample reported dyspnea or exhibited signs of Horner\u0026rsquo;s syndrome.\u003c/p\u003e\n\u003cp\u003eThe median (IQR) morphine consumption in the PARR was 0 (0\u0026ndash;0) mg in the \u003cstrong\u003eI\u003c/strong\u003e group compared with 0 (0\u0026ndash;3) in the \u003cstrong\u003eC\u003c/strong\u003e group (p=0.149). The median (IQR) length of stay in the ARDS was 60 (60\u0026ndash;82.5) min in the \u003cstrong\u003eI\u003c/strong\u003e group compared with 75 (60\u0026ndash;90) min in the \u003cstrong\u003eC\u003c/strong\u003e group (p=0.174) (Table 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003e2\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp; \u0026nbsp; Morphine consumption in mg and length of stay in PARR\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"102%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eI\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eC\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ep\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003eMorphine consumption (mg)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e0 (0\u0026ndash;0) *\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e0 (0\u0026ndash;3) *\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cem\u003ep=0\u003c/em\u003e,149\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003eTime in PARR (min)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e60(60\u0026ndash;82,5)*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e75(60\u0026ndash;90)*\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cem\u003ep=0\u003c/em\u003e,174\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 38px;\"\u003e\n \u003cp\u003e* median (IQR)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eA post-hoc sample size analysis was conducted based on the prevalence of morphine use in the PACU, which was 32.5%. Consequently, the sample of 40 cases demonstrated a statistical power of 0.807 (80.7%) to detect a significant difference.\u003c/p\u003e"},{"header":" DISCUSSION","content":"\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;This study found no statistically significant difference in immediate postoperative morphine consumption between the group that received the clavipectoral fascia block combined with the intermediate cervical plexus block and the group that received only the intermediate cervical plexus block under general intravenous anesthesia. Similarly, there was no significant difference in the duration of stay in the post-anesthesia care unit (PACU).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; Tran et al.(4) highlighted the variability in the description of clavicle innervation in the literature. Leurcharusmee et al.(5), after analyzing the innervation of 40 clavicles from fresh cadavers, identified the supraclavicular nerve as the primary nerve responsible for innervating the middle third of the clavicle. Our findings align with this, as no difference in morphine consumption was observed between the two groups, suggesting that the supraclavicular nerve, derived from the cervical plexus, plays a critical role not only in the innervation of the skin and subcutaneous tissue over the clavicle but also in the periosteum of the clavicle middle third.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; Abdelghany et al.(6) also reported no difference in perioperative analgesia between patients receiving only the intermediate cervical plexus block and those receiving a combination of the interscalene brachial plexus block with the cervical plexus block for middle-third clavicle surgeries. Our results corroborate these findings, reinforcing the role of the intermediate cervical plexus block in this clinical scenario.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; Herring et al.(12) demonstrated the success of ultrasound-guided cervical plexus blocks in providing adequate analgesia for patients with middle-third clavicle fractures in the emergency department. Finlayson et al.(13) further emphasized that ultrasound-guided intermediate cervical plexus blocks were more effective than techniques relying solely on anatomical landmarks for local anesthetic injection. This might explain the similar outcomes observed in our study, where ultrasound guidance was used for all procedures.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; Zhuo et al.(7) demonstrated a low incidence of diaphragmatic paralysis when combining the clavipectoral fascia block with the intermediate cervical plexus block compared to the interscalene brachial plexus block. In our study, no clinical signs suggestive of phrenic nerve paralysis or Horner’s syndrome were observed. However, it cannot be ruled out that some patients might have experienced subclinical phrenic nerve paralysis, a potential limitation of this study.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; One significant limitation of our study is that the protocol did not include clinical verification of block efficacy. Since the clavipectoral fascia block is a painful procedure, it was performed under general anesthesia for patient comfort, which prevented clinical assessment of its immediate effectiveness. This limitation should be addressed in future studies.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; Another limitation was the lack of assessment of analgesia beyond the immediate postoperative period. Previous studies have reported that regional blocks with ropivacaine typically last 12 to 18 hours at the concentration used in this study. For the Clavipectoral block, Sabaa et al.(14) found that analgesia lasted for about 12 hours when using a mixture of 0.5% bupivacaine and 2% lidocaine.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; Additionally, this study did not include a comparison with a group receiving only general intravenous anesthesia without any regional techniques. Banerjee et al.(15) demonstrated that patients receiving only general anesthesia experienced higher postoperative pain, greater opioid consumption, and longer PACU stays compared to those receiving regional anesthesia in combination with general anesthesia. Future studies should consider including a control group without regional anesthesia to better understand its impact on postoperative outcomes.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; In conclusion, this study found no statistically significant difference in immediate postoperative morphine consumption between the group that received the clavipectoral fascia block combined with the intermediate cervical plexus block and the group that received only the intermediate cervical plexus block under general intravenous anesthesia. Controlled studies are needed to further evaluate and determine the most effective anesthetic and analgesic techniques for patients undergoing middle-third clavicle fracture surgeries.\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cu\u003eEthics and Trial Registry Section:\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eHuman Ethics and Consent: The study received prior approval from the Institutional Research Ethics Committee at Hospital Governador Celso Ramos, with approval number 4.365.270. Additionally, all participants provided signed informed consent.\u003c/p\u003e\n\u003cp\u003eFunding: there was no specific funding allocated for this study.\u003c/p\u003e\n\u003cp\u003eTrial Number: Clinical trial registration number U1111-1255-2364 from the Brazilian Registry of Clinical Trials (ReBEC). Date of Registry: 08/25/2020. The study was retrospectively registered. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConsent for publication: Not Applicable\u003c/p\u003e\n\u003cp\u003eData Availability: The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request.\u003c/p\u003e"},{"header":"REFERENCES","content":"\u003col\u003e\n \u003cli\u003eMiao Qin M, Shishun Zhao, PhDa, Wenlai Guo, PhDb, Li Tang, MSa, Hangyu Li, MSa, Xuejie Wang, MSb,, Zhe Zhu P, \u0026lowast;, Tianwen Sun, PhDc. Open reduction and plate fixation compared with non-surgical treatment for displaced midshaft clavicle fracture A meta-analysis of randomized clinical trials. Medicine (Baltimore). 2019;98(20):9.\u003c/li\u003e\n \u003cli\u003eWolf S, Chitnis AS, Manoranjith A, Vanderkarr M, Plaza JQ, Gador LV, et al. Surgical treatment, complications, reoperations, and healthcare costs among patients with clavicle fracture in England. Bmc Musculoskel Dis. 2022;23(1).\u003c/li\u003e\n \u003cli\u003eVajapey SP, Contreras ES, Neviaser AS, Bishop JY, Cvetanovich GL. Outpatient Total Shoulder Arthroplasty: A Systematic Review Evaluating Outcomes and Cost-Effectiveness. JBJS Rev. 2021;9(5).\u003c/li\u003e\n \u003cli\u003eTran DQ, Tiyaprasertkul W, Gonz\u0026aacute;lez AP. Analgesia for clavicular fracture and surgery: a call for evidence. Reg Anesth Pain Med. 2013;38(6):539-43.\u003c/li\u003e\n \u003cli\u003eLeurcharusmee P, Maikong N, Kantakam P, Navic P, Mahakkanukrauh P, Tran Q. Innervation of the clavicle: a cadaveric investigation. Reg Anesth Pain Med. 2021;46(12):1076-9.\u003c/li\u003e\n \u003cli\u003eAbdelghany MS, Ahmed SA, Afandy ME. Superficial cervical plexus block alone or combined with interscalene brachial plexus block in surgery for clavicle fractures: a randomized clinical trial. Minerva Anestesiol. 2021;87(5):523-32.\u003c/li\u003e\n \u003cli\u003eZhuo Q, Zheng Y, Hu Z, Xiong J, Wu Y, Zheng Y, et al. Ultrasound-Guided Clavipectoral Fascial Plane Block With Intermediate Cervical Plexus Block for Midshaft Clavicular Surgery: A Prospective Randomized Controlled Trial. Anesth Analg. 2022;135(3):633-40.\u003c/li\u003e\n \u003cli\u003eVald\u0026eacute;s-Vilches LF, editor Analgesia for clavicular surgery/fractures. In Symposia 01: Postoperative analgesia for Orthopedic upper and lower limb surgery. . Symposium conducted at the 36th Annual European Society of Regional Anaesthesia and Pain Therapy (ESRA) Congress; 2017; Lugano, Switzerland.\u003c/li\u003e\n \u003cli\u003eLabandeyra H, Heredia C, Valdes-Vilches LF, Prats-Galino A, Sala-Blanch X. Clavipectoral fascia plane block in midshaft clavicle fractures: A cadaveric study. J Clin Anesth. 2024;96:111469.\u003c/li\u003e\n \u003cli\u003eKim HY, Soh EY, Lee J, Kwon SH, Hur M, Min SK, et al. Incidence of hemi-diaphragmatic paresis after ultrasound-guided intermediate cervical plexus block: a prospective observational study. J Anesth. 2020;34(4):483-90.\u003c/li\u003e\n \u003cli\u003eJin-Soo Kim JSK, Seunguk Bang,, Hyungtae Kim aSYL. Cervical plexus block. Korean Journal of Anesthesiology. 2018;71(4):15.\u003c/li\u003e\n \u003cli\u003eHerring AA, Stone MB, Frenkel O, Chipman A, Nagdev AD. The ultrasound-guided superficial cervical plexus block for anesthesia and analgesia in emergency care settings. Am J Emerg Med. 2012;30(7):1263-7.\u003c/li\u003e\n \u003cli\u003eTran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010;35(6):539-43.\u003c/li\u003e\n \u003cli\u003eAbu Sabaa MA, Elbadry AA, El Malla DA. Ultrasound-Guided Clavipectoral Block for Postoperative Analgesia of Clavicular Surgery: A Prospective Randomized Trial. Anesth Pain Med. 2022;12(1):e121267.\u003c/li\u003e\n \u003cli\u003eBanerjee S, Acharya R, Sriramka B. Ultrasound-Guided Inter-scalene Brachial Plexus Block with Superficial Cervical Plexus Block Compared with General Anesthesia in Patients Undergoing Clavicular Surgery: A Comparative Analysis. Anesth Essays Res. 2019;13(1):149-54.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"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":"bmc-anesthesiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bane","sideBox":"Learn more about [BMC Anesthesiology](http://bmcanesthesiol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bane","title":"BMC Anesthesiology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Analgesia, Morphine, Cervical plexus, Clavicle, Regional anesthesia, Fractures, bone","lastPublishedDoi":"10.21203/rs.3.rs-5327123/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5327123/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Midshaft clavicular fractures account for approximately 5% of bone fractures. Surgical correction is often necessary to ensure adequate functional recovery. There is no consensus in the literature on which Regional Anesthesia method should be used to provide appropriate postoperative analgesia. The aim of this study was to evaluate the quality of immediate postoperative analgesia by recording morphine consumption and time spent in the post-anesthesia care unit, following clavipectoral fascia block associated with intermediate cervical plexus block compared to intermediate cervical plexus block alone, in surgical operations for fracture synthesis after midshaft clavicle fracture.\u003c/p\u003e\n\u003cp\u003eMethods: Forty patients undergoing surgical operations for midshaft clavicle fracture correction were randomly allocated into two groups: intermediate cervical plexus block associated with clavipectoral fascia block (Group I) and intermediate cervical plexus block alone (Group C). After applying the inclusion and exclusion criteria, and under general anesthesia, the patients received one of the described blocks. Data were blinded for analysis, and a significance level of 5% was considered.\u003c/p\u003e\n\u003cp\u003eResults: The median (IQR) morphine consumption in the PACU for Group I was 0 (0-0) mg compared to 0 (0-3) mg for Group C (p=0.149). The median (IQR) PACU stay time for Group I was 60 (60-82.5) minutes compared to 75 (60-90) minutes for Group C (p=0.174).\u003c/p\u003e\n\u003cp\u003eConclusion: Under the conditions of this study, the clavipectoral fascia block, whether associated with or without the intermediate cervical plexus block, did not result in significant differences between the groups in terms of immediate postoperative morphine consumption or PACU stay time.\u003c/p\u003e\n\u003cp\u003eTrial Registration: The study was registered with the Brazilian Registry of Clinical Trials (ReBEC) under number U1111-1255-2364.\u003c/p\u003e","manuscriptTitle":"Clavipectoral fascia block associated with intermediate cervical plexus block versus intermediate cervical plexus block alone in clavicle surgeries: a randomized clinical trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-31 10:05:21","doi":"10.21203/rs.3.rs-5327123/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-02-17T09:01:13+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"271587951706061315695413109422299770245","date":"2026-02-14T15:48:43+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-02-13T17:33:17+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"154801728128531741796377946663659115224","date":"2026-02-13T16:20:06+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"39837125234202328929223486716139367554","date":"2026-01-31T06:39:05+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"48229379249248019411927954541612797408","date":"2026-01-05T09:49:47+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-12-16T08:40:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"307600105952983064225094383483722835929","date":"2024-12-13T13:17:56+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-12-05T14:41:21+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-12-02T06:18:21+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2024-11-13T04:53:31+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-11-12T17:21:23+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Anesthesiology","date":"2024-11-12T17:20:04+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-anesthesiology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bane","sideBox":"Learn more about [BMC Anesthesiology](http://bmcanesthesiol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bane","title":"BMC Anesthesiology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"64264c1d-9a16-4a25-aaca-82e426f5a647","owner":[],"postedDate":"October 31st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-11T12:29:03+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-31 10:05:21","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5327123","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5327123","identity":"rs-5327123","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}