Modified Local Anesthesia for Transperineal Prostate Biopsy: A Comparative Study of Safety and Tolerability

Modified Local Anesthesia for Transperineal Prostate Biopsy: A Comparative Study of Safety and Tolerability | 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 Article Modified Local Anesthesia for Transperineal Prostate Biopsy: A Comparative Study of Safety and Tolerability Zhijie Jiang, Xin Yang, Linjie Li, Shiqi Yang, Xinyi Ling, Ge Wang, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7813031/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 Objective To evaluate the safety and tolerability of a modified local anesthesia (MLA) protocol for transperineal (TP) prostate biopsy and to compare its outcomes with general anesthesia (GA) and epidural block (EB).. Patients and Methods: This retrospective study analyzed 897 patients who underwent TP prostate biopsy between January 2021 and July 2024, all performed by the same experienced urologist. Patients were divided into three groups: MLA (n = 591), GA (n = 123), or EB (n = 183). Key metrics for evaluating safety and tolerability included the visual analog scale (VAS) for pain, incidence of complications, and the cancer detection rate. Results A total of 897 patients were analyzed (591 MLA, 123 GA, 183 EB). While the MLA group reported higher pain scores during anesthesia administration compared to the EB group (mean VAS 4.41 vs. 3.95, p < 0.001), severe pain (VAS ≥ 7) was infrequent (3.89%). Notably, the MLA group exhibited a lower incidence of early complications, including urinary retention (14.2% vs. 29.3% in GA and 29.5% in EB, p < 0.001) and fever (7.3% vs. 15.4% in GA and 13.7% in EB, p = 0.003). The overall prostate cancer (PCa) detection rate in the MLA group was 54.15%, indicating comparable diagnostic efficacy. Conclusion MLA for TP biopsy is a safe and well-tolerated procedure that reduces early postoperative complications compared to GA and EB, while maintaining high diagnostic accuracy. Therefore, MLA represents a robust alternative anesthetic strategy, offering a balance between patient comfort, safety, and clinical efficiency. Biological sciences/Cancer Health sciences/Diseases Health sciences/Medical research Health sciences/Oncology Health sciences/Urology Transperineal Prostate Biopsy Prostate Cancer Modified Local Anesthesia Pain Diagnosis Figures Figure 1 Figure 2 1. Introduction PCa is the second most commonly diagnosed cancer and the sixth leading cause of cancer death among men worldwide, with an estimated 1 276 000 new cancer cases and 359 000 deaths in 2018 [ 1 ]. In recent years, due to an aging population and changes in dietary habits, the incidence of PCa has significantly increased in China [ 2 ]. The primary diagnostic and screening methods for PCa include digital rectal examination (DRE), prostate-specific antigen (PSA) serum tests, magnetic resonance imaging (MRI), and prostate biopsy [ 3 ]. Among these, transrectal ultrasound-guided prostate biopsy (TRUS) and TP are the two main diagnostic methods [ 4 ]. Traditionally, TRUS has been the preferred method for suspected PCa cases. Although this procedure is relatively simple and prophylactic antibiotics are used, about 5%-7% of patients may still experience septicemia [ 5 ]. In contrast, TP reduces the risk of septicemia [ 6 ]. Additionally, TP enables the collection of more tissue samples, which improves the accuracy and reliability of biopsies, significantly increasing the cancer detection rate, especially in the antero-apical portions of the prostate [ 7 , 8 ]. Due to the dense distribution of nerves in the perineum, TP usually requires either spinal anesthesia or general anesthesia to ensure patient cooperation, and this procedure often requires monitoring by anesthesiologists. Currently, there is no standardized anesthesia protocol for transperineal biopsy. The literature reports various anesthesia techniques, including spinal anesthesia, pudendal nerve block, periprostatic nerve block, and other local anesthesia methods, as well as general anesthesia [ 9 ]. While local anesthesia is a common approach for TP biopsy, conventional techniques often involve single-point, superficial injections, leading to inadequate anesthetic coverage and suboptimal pain control [ 10 ]. To address these limitations, we developed a MLA technique. This method utilizes ultrasound guidance to perform multi-point, layered infiltrations targeting the skin, perineum, and periprostatic regions, ensuring comprehensive analgesia throughout the biopsy pathway. Unlike traditional single-injection methods, our MLA technique enhances anesthetic depth and uniformity, thereby improving patient comfort. Furthermore, it avoids the systemic risks and prolonged recovery associated with GA and EB, positioning it as a potentially safer and more efficient alternative. This study introduces and evaluates a standardized MLA technique as a viable alternative for TP biopsy. We hypothesized that this approach could reduce complication rates and enhance patient tolerance compared to GA and EB, without compromising diagnostic yield. We herein present our comparative outcomes on safety, tolerability, and cancer detection rates, aiming to provide robust evidence for the adoption of MLA in routine clinical practice. 2. Patients and Methods 2.1 Patients This retrospective, non-randomized, comparative study was conducted to reflect real-world clinical practice. Patient allocation to the MLA, GA, or EB group was based on a comprehensive anesthetic risk assessment by a multidisciplinary team and incorporated patient preference. To mitigate potential selection bias inherent in this pragmatic design, we retrospectively collected data and rigorously compared the baseline clinical and demographic characteristics of the three cohorts to identify any significant confounding variables. To ensure adequate statistical power for evaluating the effects of different anesthesia modalities on patient pain scores (VAS) and safety outcomes, a post-hoc power analysis was performed using G*Power software. Based on an anticipated medium effect size (Cohen’s d ≈ 0.5 for two-group comparisons; f ≈ 0.25 for three-group ANOVA), with a significance level (α) of 0.05 and a statistical power (1-β) of 0.8, the analysis indicated a minimum requirement of approximately 64 patients per group for t-tests and a total of 159 patients for the overall ANOVA. Our study ultimately included 591 patients in the MLA group, 123 in the GA group, and 183 in the EB group. These sample sizes exceed the calculated minimums, providing robust statistical power for both overall and between-group analyses and ensuring the reliability of our findings. This study included 939 patients who visited the Department of Urology at the First Affiliated Hospital of Chongqing Medical University and scheduled to transperineal prostate biopsy between January 2021 and July 2024. Inclusion criteria for the study were as follows: abnormal DRE, PSA > 10 ng/ml, or PSA > 4 ng/ml with MRI demonstrating abnormal signal in the prostate, and age between 40 and 90 years. Exclusion criteria included: patients with mental illness or impaired comprehension, unable to cooperate with treatment or follow-up; patients with active anorectal disease, urinary tract infections, hematuria, chronic pelvic pain, acute urinary retention, etc.; patients with coagulation disorders or those on anticoagulant or antiplatelet therapy who had not stopped medication for at least one week; patients with severe heart disease, or those with other malignant tumors, acute infections, or other severe infections (e.g., active hepatitis B or C, urinary tract infections, etc.);patients with other severe systemic diseases that could affect treatment, assessment, or patient compliance (such as severe respiratory, circulatory, neurological, psychiatric, digestive, endocrine, immune, urological disorders, etc.); or patients in poor general condition who were unable to tolerate anesthesia or had contraindications or allergies to the study treatment. After applying exclusion criteria and accounting for 42 patients lost to follow-up, a total of 897 patients successfully underwent TP. Among the included patients, 591 underwent MLA, 123 received GA, and 183 received epidural anesthesia EB. All prostate biopsies were performed by an experienced urologist. Informed consent was obtained from all patients prior to their procedure, and the study was approved by the Ethics Committee of The First Affiliated Hospital of Chongqing Medical University. Basic information was retrospectively collected from patients, including age, height, weight, serum PSA levels, MRI Prostate Imaging Reporting and Data System (PI-RADS) scores, early and late postoperative complications, biopsy positive results, and Gleason scores. 2.2 Anesthesia and Biopsy Procedure On the evening before or the morning of the procedure, all patients underwent bowel preparation with a 110 ml glycerin enema. One hour before the biopsy, all patients received prophylactic intravenous antibiotics—either a cephalosporin (cefuroxime) or levofloxacin (500 mg)—to reduce the risk of infection. For anesthesia, lidocaine hydrochloride injection (5 ml: 0.1 g) was diluted with 0.9% sodium chloride solution to a total volume of 15 ml. Prior to anesthetic administration, patients were placed in the lithotomy position, and the surgical field was prepared and draped in a sterile manner. A 2% lidocaine gel was applied to the ultrasound probe (linear probe, 7.5 MHz, Hitachi Arietta V70), which was then inserted into the rectum. Centered 1.5 cm anterior to the anal verge, a 0.45 × 16 mm needle was used to perform superficial infiltration anesthesia in a fan-shaped area on both sides (Fig. 1 A), with 2 ml of the diluted anesthetic injected per side, effectively reducing pain and discomfort caused by the skin puncture. Next, a 0.8 × 38 mm needle was used to puncture from the area of prior superficial infiltration (Fig. 1 B). Under ultrasound guidance, approximately 5 ml of anesthetic was precisely injected at both the apex and posterolateral regions of the prostate (Fig. 2 ), on each side sequentially. During injection, the needle was slowly withdrawn, allowing the anesthetic to fully infiltrate the muscles (such as the Musculus Bulbospongiosus and Musculus Transversus Perinei Profundus), nerves (including the perineal nerve and its branches), and nociceptive nerve endings (Figs. 1 C and 1 D) adjacent to the biopsy tract, thereby achieving effective deep anesthesia. Throughout the procedure, real-time ultrasound monitoring was employed to ensure accurate needle positioning and even distribution of the anesthetic within the target tissues, significantly enhancing the depth and efficacy of anesthesia and effectively mitigating pain during the biopsy. This anesthesia technique combines superficial and deep multipoint infiltration, ensuring patient comfort, avoiding the risks associated with general anesthesia, and consequently improving both the safety and tolerability of the procedure. After anesthesia was completed, a 2-minute waiting period was allowed to ensure the anesthetic took effect. The same operator then performed the transperineal biopsy using a systematic multi-needle approach. An 18-gauge needle was used to biopsy 3–5 samples from suspicious lesions identified on preoperative MRI and ultrasound images, with additional biopsies performed on the left and right prostate sides (5–8 samples each) and 3–5 samples from the base region. All biopsies were conducted under ultrasound guidance, with the needle's tip observed breaking through the capsule and obtaining tissue samples. After the procedure, pressure was applied to the perineal area with iodine gauze for 3 minutes, and patients were monitored for 15 minutes before returning to the ward. This multi-point, layered infiltration technique was designed to provide comprehensive analgesia from the skin to the periprostatic region, ensuring patient comfort throughout the procedure. 2.3 Data Collection and Observation Indicators Pain assessment was performed using the VAS [ 11 ], where a score of 0 indicated no pain, 1–3 indicated mild pain, 4–6 indicated moderate pain, and 7–10 indicated severe pain. During the procedure, an experienced urology nurse who was not involved in this study conducted multiple VAS pain assessments at three stages: during anesthetic administration, during the prostate biopsy itself, and within 15 minutes after completion of the biopsy. For each stage, the highest VAS score was selected for subsequent statistical analysis. To capture the peak pain intensity during each phase, the maximum VAS score reported by the patient was recorded for statistical analysis. This approach was chosen to provide a stringent assessment of the anesthetic regimen's efficacy in managing procedural pain. Information was retrospectively collected on patients’ age, height, weight, serum PSA level, and PI-RADS score, as well as data on early and late complications. For patients diagnosed with PCa, the Gleason grade group was also recorded. Early complications were defined as adverse events occurring within 30 days after the procedure, primarily including perineal pain, urinary retention, fever (body temperature > 38°C), infections (such as urinary tract infection and sepsis), as well as anesthesia-related symptoms like headache and nausea. These events are mainly associated with the biopsy procedure or anesthesia itself. Late complications were defined as those occurring or persisting more than 30 days postoperatively, including persistent or recurrent urinary retention, delayed-onset infections, and rehospitalization due to any procedure-related complication [ 5 , 8 ]. Safety monitoring indicators include potential allergic and toxic reactions to anesthetic drugs during the procedure, as well as the incidence of postoperative complications such as hematuria, hematochezia, perineal hematoma, urinary retention, pain at the puncture site, numbness, and abnormal skin sensations around the penis and perineum. 2.4 Statistical Analysis Statistical analysis was performed using SPSS Statistics for Windows version 26 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as mean ± standard deviation, and categorical variables were presented as n (%). Differences in age, PSA levels, prostate volume, BMI, and VAS scores between the three groups were compared using one-way analysis of variance (ANOVA). Differences in early/late complications and detection rates between the three groups were analyzed using chi-square tests. According to the PSA levels and PI-RADS scores in the MLA group, patients were divided into different subgroups, and the PCa detection rates in each subgroup were compared. A P value of < 0.05 was considered statistically significant. 3. Results A total of 897 patients were included in this study. Among them, 591 patients received MLA, 123 patients received GA, and 183 patients received EB. The clinical characteristics of patients in each group are shown in Table 1 . Table 1 Baseline clinical characteristics of patients in the three anesthesia groups. Variable Mean ± SD Overall P value MLA GA EB Age (year) 68.60 ± 8.43 67.60 ± 7.99 67.70 ± 8.19 68.27 ± 8.33 0.291 PSA (ng/ml) 48.40 ± 112.00 36.50 ± 87.10 31.20 ± 80.90 43.21 ± 103.59 0.108 Prostate volume (cm³) 51.80 ± 12.90 53.40 ± 9.93 52.70 ± 13.20 52.22 ± 12.59 0.391 BMI (kg/m²) 24.90 ± 5.47 23.80 ± 3.27 24.20 ± 6.42 24.58 ± 5.45 0.064 The mean age of the patients was 68.27 ± 8.33 years, the average PSA value was 43.21 ± 103.59 ng/ml, the measured prostate volume via TRUS was 52.22 ± 12.59 cm³, and the mean BMI was 24.58 ± 5.45 kg/m². No significant differences were observed in baseline data between the groups . Pain scores, recorded at the anesthesia, biopsy, and postoperative stages, are detailed in Table 2 . During the anesthesia stage, where the score for the GA group reflects procedural pain from intravenous cannulation before induction, a difference was found among the groups (p < 0.001), with the EB group experiencing less pain than the MLA group. This trend continued during the biopsy phase, where the MLA group's VAS scores were significantly higher than the EB group's (p 0.05). Table 2 VAS pain scores across three procedural stages. Variable VAS(Mean ± SD) P value MLA GA EB Anesthesia 4.41 ± 1.30 4.15 ± 1.20 3.95 ± 0.93 <0.001 Biopsy 3.10 ± 1.02 – 1.82 ± 0.70 <0.001 Postoperation 0.98 ± 0.44 1.00 ± 0.54 1.03 ± 0.37 0.342 Note: VAS score for the biopsy phase in the GA group is not applicable because patients under GA are unconscious during the biopsy procedure and therefore do not report pain in this phase. Patients most frequently reported that infiltration of the skin was the most painful part of the anesthesia stage. Crucially, despite these statistical differences, the MLA was clinically well-tolerated. Only 3.89% of patients (23/591) in the MLA group reported severe pain (VAS 7–10) during anesthesia, and in these cases, the procedure was successfully completed after the anesthetic dose was increased. In terms of early complications, significant differences were found between the groups in urinary retention (p < 0.001), fever (p = 0.003), and anesthesia-related headaches and nausea (p < 0.001), with these complications mainly occurring in the GA group, and the MLA group had the lowest incidence. No significant differences were found between the three groups for late complications (including urinary retention, fever, and readmission) (Table 3 ). No major postoperative complications occurred in any group, and all early complications were resolved within 72 hours, with patients being discharged. Table 3 Incidence of early and late complications by anesthesia group. Variable MLA(n%) GA(n%) EB(n%) P value Early complications pain of perineum 88(14.9%) 14(11.4%) 24(13.1%) 0.548 urinary retention 84(14.2%) 36(29.3%) 54(29.5%) 38°C 43(7.3%) 19(15.4%) 25(13.7%) 0.003 Sepsis 10(1.7%) 4(3.3%) 2(1.1%) 0.381 Headache or nausea 27(4.6%) 19(15.4%) 30(16.4%) 38°C 15(2.5%) 5(4.1%) 8(4.4%) 0.337 Rehospitalization 2(0.3%) 0(0.0%) 1(0.5%) 0.715 In the MLA group, the overall PCa detection rate was 54.15% (320/591). The PCa detection rates for different PI-RADS scores were as follows: PI-RADS 3 was 34.3% (49/143), PI-RADS 4 was 53.5% (92/172), and PI-RADS 5 was 90.0% (153/170) (Table 4 ). The PCa detection rates for PSA levels of 20 ng/ml were 39.0% (73/187), 41.1% (72/175), and 76.4% (175/229), respectively. Compared to previous literature, the detection rate in patients with PSA < 10 ng/ml was slightly higher, while the detection rates for other PSA levels were consistent with previously reported ranges [ 12 ]. Table 4 PCa detection rates in the MLA group stratified by PI-RADS score and PSA level. Variable Detection rate(n%) MLA Previous literature PSA(ng/ml) 20 175/229(76.4%) 56%-80% PI-RADS 3 49/143(34.3%) 30%-45% 4 92/172(53.5%) 47%-65% 5 153/170(90.0%) 83%-94% 4. Discussion This study demonstrates that our MLA protocol for prostate biopsy is a well-tolerated and safe alternative to GA and EB, offering significant advantages in reducing early postoperative complications without compromising diagnostic accuracy. Our findings support the adoption of MLA as a robust anesthetic strategy in routine clinical practice. Our primary finding confirms that MLA is a well-tolerated procedure. Although the mean VAS score during anesthetic administration was statistically higher in the MLA group compared to the EB group (4.41 vs. 3.95), the absolute difference of less than 0.5 points on a 10-point scale is of limited clinical significance. More importantly, severe pain (VAS ≥ 7) was infrequent (3.89%), and no procedures were terminated due to discomfort, underscoring the clinical feasibility and high patient acceptance of this technique. Anecdotally, a high preference for MLA was reported by patients with prior biopsy experience under other anesthetic methods, further highlighting its excellent tolerability. The second major finding relates to the superior safety profile of MLA, particularly concerning early postoperative complications. The MLA group exhibited lower rates of urinary retention and fever compared to both GA and EB groups. The reduced incidence of urinary retention is a key advantage, likely attributable to the avoidance of prolonged motor and autonomic nerve blockade associated with EB and the bladder detrusor inhibition caused by systemic agents in GA. The lower fever rate may be multifactorial, potentially related to a shorter overall procedure time and a reduced systemic inflammatory response compared to more invasive anesthetic methods, a hypothesis that warrants further investigation. Crucially, these improvements in safety and tolerability were not achieved at the expense of diagnostic efficacy. The overall prostate cancer detection rate in the MLA group (54.15%) was robust. When stratified by risk, the diagnostic yield was consistent with or even exceeded established benchmarks. For instance, the detection rate of 90.0% in patients with PI-RADS 5 lesions aligns well with the 83%-94% range reported in contemporary studies, and the 76.4% detection rate for PSA levels > 20 ng/ml falls squarely within the expected 56%-80% range. Notably, our 39.0% detection rate in the low-PSA (< 10 ng/ml) subgroup is at the higher end of the typically reported 20%-30% range, which may suggest an enhanced sampling capability facilitated by the TP approach under MLA, although this requires further confirmation. The success of our protocol is rooted in the refined MLA technique itself. Unlike conventional single-point, superficial injections, our method employs a multi-point, layered infiltration strategy. It begins with a fan-shaped superficial block to numb the skin, followed by precise, ultrasound-guided deep infiltration at the prostatic apex and posterolateral aspects. This ensures comprehensive analgesia along the entire biopsy pathway, from the skin to the periprostatic nerves. This efficient technique not only enhances patient comfort but also streamlines the clinical workflow. The entire procedure takes only 12–15 minutes and is more cost-effective as it obviates the need for an anesthesiologist and a formal operating room. Furthermore, as the operator's proficiency grew, we successfully omitted prophylactic antibiotics in the final 112 patients of the MLA cohort without any subsequent infectious complications. While preliminary, this promising observation suggests that antibiotic-free TP biopsy under MLA may be feasible, a significant advantage that warrants validation in future prospective trials. Our findings contribute to the growing body of evidence supporting the shift from transrectal to transperineal biopsies to minimize infectious complications [ 13 – 15 ]. We advocate for a freehand biopsy technique, which offers greater flexibility and cost-effectiveness over needle-guided probes, though we acknowledge it involves a learning curve, estimated at approximately 20 cases for a novice urologist to achieve proficiency. This study has several limitations that must be acknowledged. First, its single-center, retrospective, non-randomized design means that patient grouping was subject to clinical judgment and patient preference, potentially introducing selection bias. Second, all biopsies were performed by a single experienced urologist to ensure procedural consistency, which strengthens internal validity but may limit the generalizability of our findings to operators with varying levels of experience. Finally, the study lacked a direct comparison with TRUS biopsy. To build upon these promising findings, future research should prioritize large-scale, multi-center randomized controlled trials. Such trials are needed to confirm our results and should directly compare MLA with GA, EB, and TRUS approaches. These studies should incorporate formal non-inferiority testing for pain outcomes, a comprehensive cost-effectiveness analysis, and a structured evaluation of the learning curve for urologists new to the MLA technique. 5. Conclusion In conclusion, this study provides robust evidence that TP biopsy under MLA is not only safe and well-tolerated but also superior to GA and EB in reducing early postoperative complications, such as fever and urinary retention. With comparable diagnostic accuracy, excellent patient acceptance, and potential for cost and resource savings, MLA is a suitable anesthetic option for transperineal prostate biopsy in routine clinical practice. Abbreviations TP Transperineal Prostate Biopsy MLA Modified Local Anesthesia GA General Anesthesia EB Epidural Block PSA Prostate-Specific Antigen DRE Digital Rectal Examination VAS Visual Analog Scale PCa Prostate Cancer TRUS Transrectal Ultrasound-guided Biopsy PI-RADS Prostate Imaging Reporting and Data System Declarations Ethics declaration This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of The First Affiliated Hospital of Chongqing Medical University (Approval No. 2021-307). Written informed consent was obtained from all participants involved in the study. Competing interests The authors declare that they have no competing interests. Funding This work was sponsored by the National Natural Science Foundation of China to Fei Gao (No. 82370691). Furthermore, it was sponsored by Chongqing Science and Health Joint project (No.2020GDRC007), Senior Medical Talents Program of Chongqing for Yong and Middle-aged (No. 204216qn) ， Reserve Talents Program for Academic Leaders of the First Affiliated Hospital of Chongqing Medical University (No. XKTS070) to Fei Gao. Finally, this work was also sponsored by Natural Science Foundation of Chongqing, China to Fei Gao (No. CSTB2023NSCQ-MSX0072) and Mei Yang(No. CSTB2023NSCQ- MSX0565). Authorship contribution statement Conceptualization, Zhijie Jiang, Xin Yang, Linjie Li and Fei Gao; Data curation, Shiqi Yang, Xinyi Ling, Ge Wang and Xiaowen Huang; Formal analysis, Zhijie Jiang, Xin Yang and Linjie Li; Funding acquisition, Fei Gao; Investigation, Zhijie Jiang, Xin Yang and Linjie Li; Methodology, Zhijie Jiang, Xin Yang and Linjie Li; Project administration, Fei Gao; Resources, Fei Gao; Software, Zhijie Jiang, Xin Yang and Linjie Li; Supervision, Fei Gao; Validation, Zhijie Jiang, Xin Yang and Linjie Li; Writing – original draft, Zhijie Jiang, Xin Yang and Linjie Li; Writing – review & editing, Zhijie Jiang, Xin Yang, Linjie Li and Fei Gao. Data availability The data that support the findings of this study are available from the corresponding author upon reasonable request. Acknowledgements We acknowledge all participants for their help in facilitating this research. Patient consent for publication Not applicable. References Culp, M. 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Gao","email":"data:image/png;base64,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","orcid":"","institution":"The First Affiliated Hospital of Chongqing Medical University","correspondingAuthor":true,"prefix":"","firstName":"Fei","middleName":"","lastName":"Gao","suffix":""}],"badges":[],"createdAt":"2025-10-09 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08:10:47","extension":"xml","order_by":13,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":69671,"visible":true,"origin":"","legend":"","description":"","filename":"e0822b18d5b54b38b2edcb8c091ecdfd1structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7813031/v1/3a28be6a9e2645413590e996.xml"},{"id":97124388,"identity":"43c35497-028f-454e-b34b-e991f1ed39f2","added_by":"auto","created_at":"2025-12-01 08:10:48","extension":"html","order_by":14,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":79281,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7813031/v1/32f4979c887446e3f1e33940.html"},{"id":97142718,"identity":"478bd62a-53c8-475b-856e-794907ab48b9","added_by":"auto","created_at":"2025-12-01 10:07:55","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1564466,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSchematic illustration of the MLA technique. \u003c/strong\u003e(A) Schematic sagittal view of pelvic anatomy relevant to transperineal prostate biopsy. (B) Anatomical illustration of the perineal nerves, particularly the pudendal nerve and its branches. (C) Superficial fan-shaped infiltration anesthesia. (D) Deep infiltration anesthesia targeting the periprostatic region. MB, Musculus Bulbospongiosus; MTPP, Musculus Transversus Perinei Profundus; CS, Corpus Spongiosum.\u003c/p\u003e","description":"","filename":"Figure1.tiff.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7813031/v1/982f7f07e49a37b74553d469.jpg"},{"id":97124378,"identity":"c9de15f5-2079-45fb-b161-cf921c42b4b6","added_by":"auto","created_at":"2025-12-01 08:10:47","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1198110,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eUltrasound-guided deep infiltration anesthesia of the prostate. \u003c/strong\u003e(A, B) Real-time ultrasound images showing the needle tip positioned at the (A) prostatic apex and (B) posterolateral aspect. (C, D) Images showing the diffusion of the anesthetic agent within the periprostatic tissues during injection.\u003c/p\u003e","description":"","filename":"Figure2.tiff.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7813031/v1/7c76b486a80ce029ddf9085b.jpg"},{"id":97240456,"identity":"f139d8ae-47ab-4447-9c68-ca773d4451bd","added_by":"auto","created_at":"2025-12-02 11:09:10","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":3565124,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7813031/v1/f745fbe4-c24f-46b5-a96d-ac36ee0c53c7.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Modified Local Anesthesia for Transperineal Prostate Biopsy: A Comparative Study of Safety and Tolerability","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003ePCa is the second most commonly diagnosed cancer and the sixth leading cause of cancer death among men worldwide, with an estimated 1 276 000 new cancer cases and 359 000 deaths in 2018 [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. In recent years, due to an aging population and changes in dietary habits, the incidence of PCa has significantly increased in China [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. The primary diagnostic and screening methods for PCa include digital rectal examination (DRE), prostate-specific antigen (PSA) serum tests, magnetic resonance imaging (MRI), and prostate biopsy [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Among these, transrectal ultrasound-guided prostate biopsy (TRUS) and TP are the two main diagnostic methods [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eTraditionally, TRUS has been the preferred method for suspected PCa cases. Although this procedure is relatively simple and prophylactic antibiotics are used, about 5%-7% of patients may still experience septicemia [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. In contrast, TP reduces the risk of septicemia [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Additionally, TP enables the collection of more tissue samples, which improves the accuracy and reliability of biopsies, significantly increasing the cancer detection rate, especially in the antero-apical portions of the prostate [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Due to the dense distribution of nerves in the perineum, TP usually requires either spinal anesthesia or general anesthesia to ensure patient cooperation, and this procedure often requires monitoring by anesthesiologists. Currently, there is no standardized anesthesia protocol for transperineal biopsy. The literature reports various anesthesia techniques, including spinal anesthesia, pudendal nerve block, periprostatic nerve block, and other local anesthesia methods, as well as general anesthesia [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eWhile local anesthesia is a common approach for TP biopsy, conventional techniques often involve single-point, superficial injections, leading to inadequate anesthetic coverage and suboptimal pain control [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. To address these limitations, we developed a MLA technique. This method utilizes ultrasound guidance to perform multi-point, layered infiltrations targeting the skin, perineum, and periprostatic regions, ensuring comprehensive analgesia throughout the biopsy pathway. Unlike traditional single-injection methods, our MLA technique enhances anesthetic depth and uniformity, thereby improving patient comfort. Furthermore, it avoids the systemic risks and prolonged recovery associated with GA and EB, positioning it as a potentially safer and more efficient alternative.\u003c/p\u003e\u003cp\u003eThis study introduces and evaluates a standardized MLA technique as a viable alternative for TP biopsy. We hypothesized that this approach could reduce complication rates and enhance patient tolerance compared to GA and EB, without compromising diagnostic yield. We herein present our comparative outcomes on safety, tolerability, and cancer detection rates, aiming to provide robust evidence for the adoption of MLA in routine clinical practice.\u003c/p\u003e"},{"header":"2. Patients and Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 Patients\u003c/h2\u003e\u003cp\u003eThis retrospective, non-randomized, comparative study was conducted to reflect real-world clinical practice. Patient allocation to the MLA, GA, or EB group was based on a comprehensive anesthetic risk assessment by a multidisciplinary team and incorporated patient preference. To mitigate potential selection bias inherent in this pragmatic design, we retrospectively collected data and rigorously compared the baseline clinical and demographic characteristics of the three cohorts to identify any significant confounding variables.\u003c/p\u003e\u003cp\u003eTo ensure adequate statistical power for evaluating the effects of different anesthesia modalities on patient pain scores (VAS) and safety outcomes, a post-hoc power analysis was performed using G*Power software. Based on an anticipated medium effect size (Cohen\u0026rsquo;s d\u0026thinsp;\u0026asymp;\u0026thinsp;0.5 for two-group comparisons; f\u0026thinsp;\u0026asymp;\u0026thinsp;0.25 for three-group ANOVA), with a significance level (α) of 0.05 and a statistical power (1-β) of 0.8, the analysis indicated a minimum requirement of approximately 64 patients per group for t-tests and a total of 159 patients for the overall ANOVA. Our study ultimately included 591 patients in the MLA group, 123 in the GA group, and 183 in the EB group. These sample sizes exceed the calculated minimums, providing robust statistical power for both overall and between-group analyses and ensuring the reliability of our findings.\u003c/p\u003e\u003cp\u003eThis study included 939 patients who visited the Department of Urology at the First Affiliated Hospital of Chongqing Medical University and scheduled to transperineal prostate biopsy between January 2021 and July 2024. Inclusion criteria for the study were as follows: abnormal DRE, PSA\u0026thinsp;\u0026gt;\u0026thinsp;10 ng/ml, or PSA\u0026thinsp;\u0026gt;\u0026thinsp;4 ng/ml with MRI demonstrating abnormal signal in the prostate, and age between 40 and 90 years. Exclusion criteria included: patients with mental illness or impaired comprehension, unable to cooperate with treatment or follow-up; patients with active anorectal disease, urinary tract infections, hematuria, chronic pelvic pain, acute urinary retention, etc.; patients with coagulation disorders or those on anticoagulant or antiplatelet therapy who had not stopped medication for at least one week; patients with severe heart disease, or those with other malignant tumors, acute infections, or other severe infections (e.g., active hepatitis B or C, urinary tract infections, etc.);patients with other severe systemic diseases that could affect treatment, assessment, or patient compliance (such as severe respiratory, circulatory, neurological, psychiatric, digestive, endocrine, immune, urological disorders, etc.); or patients in poor general condition who were unable to tolerate anesthesia or had contraindications or allergies to the study treatment.\u003c/p\u003e\u003cp\u003eAfter applying exclusion criteria and accounting for 42 patients lost to follow-up, a total of 897 patients successfully underwent TP. Among the included patients, 591 underwent MLA, 123 received GA, and 183 received epidural anesthesia EB. All prostate biopsies were performed by an experienced urologist. Informed consent was obtained from all patients prior to their procedure, and the study was approved by the Ethics Committee of The First Affiliated Hospital of Chongqing Medical University.\u003c/p\u003e\u003cp\u003eBasic information was retrospectively collected from patients, including age, height, weight, serum PSA levels, MRI Prostate Imaging Reporting and Data System (PI-RADS) scores, early and late postoperative complications, biopsy positive results, and Gleason scores.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Anesthesia and Biopsy Procedure\u003c/h2\u003e\u003cp\u003eOn the evening before or the morning of the procedure, all patients underwent bowel preparation with a 110 ml glycerin enema. One hour before the biopsy, all patients received prophylactic intravenous antibiotics\u0026mdash;either a cephalosporin (cefuroxime) or levofloxacin (500 mg)\u0026mdash;to reduce the risk of infection.\u003c/p\u003e\u003cp\u003eFor anesthesia, lidocaine hydrochloride injection (5 ml: 0.1 g) was diluted with 0.9% sodium chloride solution to a total volume of 15 ml. Prior to anesthetic administration, patients were placed in the lithotomy position, and the surgical field was prepared and draped in a sterile manner. A 2% lidocaine gel was applied to the ultrasound probe (linear probe, 7.5 MHz, Hitachi Arietta V70), which was then inserted into the rectum. Centered 1.5 cm anterior to the anal verge, a 0.45 \u0026times; 16 mm needle was used to perform superficial infiltration anesthesia in a fan-shaped area on both sides (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eA), with 2 ml of the diluted anesthetic injected per side, effectively reducing pain and discomfort caused by the skin puncture.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eNext, a 0.8 \u0026times; 38 mm needle was used to puncture from the area of prior superficial infiltration (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eB). Under ultrasound guidance, approximately 5 ml of anesthetic was precisely injected at both the apex and posterolateral regions of the prostate (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e), on each side sequentially. During injection, the needle was slowly withdrawn, allowing the anesthetic to fully infiltrate the muscles (such as the Musculus Bulbospongiosus and Musculus Transversus Perinei Profundus), nerves (including the perineal nerve and its branches), and nociceptive nerve endings (Figs.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eC and \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eD) adjacent to the biopsy tract, thereby achieving effective deep anesthesia. Throughout the procedure, real-time ultrasound monitoring was employed to ensure accurate needle positioning and even distribution of the anesthetic within the target tissues, significantly enhancing the depth and efficacy of anesthesia and effectively mitigating pain during the biopsy.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eThis anesthesia technique combines superficial and deep multipoint infiltration, ensuring patient comfort, avoiding the risks associated with general anesthesia, and consequently improving both the safety and tolerability of the procedure.\u003c/p\u003e\u003cp\u003eAfter anesthesia was completed, a 2-minute waiting period was allowed to ensure the anesthetic took effect. The same operator then performed the transperineal biopsy using a systematic multi-needle approach. An 18-gauge needle was used to biopsy 3\u0026ndash;5 samples from suspicious lesions identified on preoperative MRI and ultrasound images, with additional biopsies performed on the left and right prostate sides (5\u0026ndash;8 samples each) and 3\u0026ndash;5 samples from the base region. All biopsies were conducted under ultrasound guidance, with the needle's tip observed breaking through the capsule and obtaining tissue samples. After the procedure, pressure was applied to the perineal area with iodine gauze for 3 minutes, and patients were monitored for 15 minutes before returning to the ward. This multi-point, layered infiltration technique was designed to provide comprehensive analgesia from the skin to the periprostatic region, ensuring patient comfort throughout the procedure.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Data Collection and Observation Indicators\u003c/h2\u003e\u003cp\u003ePain assessment was performed using the VAS [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e], where a score of 0 indicated no pain, 1\u0026ndash;3 indicated mild pain, 4\u0026ndash;6 indicated moderate pain, and 7\u0026ndash;10 indicated severe pain. During the procedure, an experienced urology nurse who was not involved in this study conducted multiple VAS pain assessments at three stages: during anesthetic administration, during the prostate biopsy itself, and within 15 minutes after completion of the biopsy. For each stage, the highest VAS score was selected for subsequent statistical analysis. To capture the peak pain intensity during each phase, the maximum VAS score reported by the patient was recorded for statistical analysis. This approach was chosen to provide a stringent assessment of the anesthetic regimen's efficacy in managing procedural pain.\u003c/p\u003e\u003cp\u003eInformation was retrospectively collected on patients\u0026rsquo; age, height, weight, serum PSA level, and PI-RADS score, as well as data on early and late complications. For patients diagnosed with PCa, the Gleason grade group was also recorded. Early complications were defined as adverse events occurring within 30 days after the procedure, primarily including perineal pain, urinary retention, fever (body temperature\u0026thinsp;\u0026gt;\u0026thinsp;38\u0026deg;C), infections (such as urinary tract infection and sepsis), as well as anesthesia-related symptoms like headache and nausea. These events are mainly associated with the biopsy procedure or anesthesia itself. Late complications were defined as those occurring or persisting more than 30 days postoperatively, including persistent or recurrent urinary retention, delayed-onset infections, and rehospitalization due to any procedure-related complication [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eSafety monitoring indicators include potential allergic and toxic reactions to anesthetic drugs during the procedure, as well as the incidence of postoperative complications such as hematuria, hematochezia, perineal hematoma, urinary retention, pain at the puncture site, numbness, and abnormal skin sensations around the penis and perineum.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4 Statistical Analysis\u003c/h2\u003e\u003cp\u003eStatistical analysis was performed using SPSS Statistics for Windows version 26 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation, and categorical variables were presented as n (%). Differences in age, PSA levels, prostate volume, BMI, and VAS scores between the three groups were compared using one-way analysis of variance (ANOVA). Differences in early/late complications and detection rates between the three groups were analyzed using chi-square tests. According to the PSA levels and PI-RADS scores in the MLA group, patients were divided into different subgroups, and the PCa detection rates in each subgroup were compared. A P value of \u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e\u003c/div\u003e"},{"header":"3. Results","content":"\u003cp\u003eA total of 897 patients were included in this study. Among them, 591 patients received MLA, 123 patients received GA, and 183 patients received EB. The clinical characteristics of patients in each group are shown in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eBaseline clinical characteristics of patients in the three anesthesia groups.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e\u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eOverall\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eP value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMLA\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eGA\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eEB\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAge (year)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e\u003cp\u003e68.60\u0026thinsp;\u0026plusmn;\u0026thinsp;8.43\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e\u003cp\u003e67.60\u0026thinsp;\u0026plusmn;\u0026thinsp;7.99\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e\u003cp\u003e67.70\u0026thinsp;\u0026plusmn;\u0026thinsp;8.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c5\"\u003e\u003cp\u003e68.27\u0026thinsp;\u0026plusmn;\u0026thinsp;8.33\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.291\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePSA (ng/ml)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e\u003cp\u003e48.40\u0026thinsp;\u0026plusmn;\u0026thinsp;112.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e\u003cp\u003e36.50\u0026thinsp;\u0026plusmn;\u0026thinsp;87.10\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e\u003cp\u003e31.20\u0026thinsp;\u0026plusmn;\u0026thinsp;80.90\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c5\"\u003e\u003cp\u003e43.21\u0026thinsp;\u0026plusmn;\u0026thinsp;103.59\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.108\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eProstate volume (cm\u0026sup3;)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e\u003cp\u003e51.80\u0026thinsp;\u0026plusmn;\u0026thinsp;12.90\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e\u003cp\u003e53.40\u0026thinsp;\u0026plusmn;\u0026thinsp;9.93\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e\u003cp\u003e52.70\u0026thinsp;\u0026plusmn;\u0026thinsp;13.20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c5\"\u003e\u003cp\u003e52.22\u0026thinsp;\u0026plusmn;\u0026thinsp;12.59\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.391\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eBMI (kg/m\u0026sup2;)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e\u003cp\u003e24.90\u0026thinsp;\u0026plusmn;\u0026thinsp;5.47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c3\"\u003e\u003cp\u003e23.80\u0026thinsp;\u0026plusmn;\u0026thinsp;3.27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e\u003cp\u003e24.20\u0026thinsp;\u0026plusmn;\u0026thinsp;6.42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c5\"\u003e\u003cp\u003e24.58\u0026thinsp;\u0026plusmn;\u0026thinsp;5.45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.064\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe mean age of the patients was 68.27\u0026thinsp;\u0026plusmn;\u0026thinsp;8.33 years, the average PSA value was 43.21\u0026thinsp;\u0026plusmn;\u0026thinsp;103.59 ng/ml, the measured prostate volume via TRUS was 52.22\u0026thinsp;\u0026plusmn;\u0026thinsp;12.59 cm\u0026sup3;, and the mean BMI was 24.58\u0026thinsp;\u0026plusmn;\u0026thinsp;5.45 kg/m\u0026sup2;. No significant differences were observed in baseline data between the groups .\u003c/p\u003e\u003cp\u003ePain scores, recorded at the anesthesia, biopsy, and postoperative stages, are detailed in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. During the anesthesia stage, where the score for the GA group reflects procedural pain from intravenous cannulation before induction, a difference was found among the groups (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), with the EB group experiencing less pain than the MLA group. This trend continued during the biopsy phase, where the MLA group's VAS scores were significantly higher than the EB group's (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Postoperatively, there was no significant difference in pain scores between the groups (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eVAS pain scores across three procedural stages.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"\u0026plusmn;\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e\u003cp\u003eVAS(Mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eP value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMLA\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eGA\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eEB\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAnesthesia\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e\u003cp\u003e4.41\u0026thinsp;\u0026plusmn;\u0026thinsp;1.30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4.15\u0026thinsp;\u0026plusmn;\u0026thinsp;1.20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e\u003cp\u003e3.95\u0026thinsp;\u0026plusmn;\u0026thinsp;0.93\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eBiopsy\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e\u003cp\u003e3.10\u0026thinsp;\u0026plusmn;\u0026thinsp;1.02\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u0026ndash;\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e\u003cp\u003e1.82\u0026thinsp;\u0026plusmn;\u0026thinsp;0.70\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePostoperation\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c2\"\u003e\u003cp\u003e0.98\u0026thinsp;\u0026plusmn;\u0026thinsp;0.44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e1.00\u0026thinsp;\u0026plusmn;\u0026thinsp;0.54\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"\u0026plusmn;\" colname=\"c4\"\u003e\u003cp\u003e1.03\u0026thinsp;\u0026plusmn;\u0026thinsp;0.37\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e0.342\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eNote:\u0026nbsp;\u003c/strong\u003eVAS score for the biopsy phase in the GA group is not applicable because patients under GA are unconscious during the biopsy procedure and therefore do not report pain in this phase.\u003c/p\u003e\u003cp\u003ePatients most frequently reported that infiltration of the skin was the most painful part of the anesthesia stage. Crucially, despite these statistical differences, the MLA was clinically well-tolerated. Only 3.89% of patients (23/591) in the MLA group reported severe pain (VAS 7\u0026ndash;10) during anesthesia, and in these cases, the procedure was successfully completed after the anesthetic dose was increased.\u003c/p\u003e\u003cp\u003eIn terms of early complications, significant differences were found between the groups in urinary retention (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), fever (p\u0026thinsp;=\u0026thinsp;0.003), and anesthesia-related headaches and nausea (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), with these complications mainly occurring in the GA group, and the MLA group had the lowest incidence. No significant differences were found between the three groups for late complications (including urinary retention, fever, and readmission) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). No major postoperative complications occurred in any group, and all early complications were resolved within 72 hours, with patients being discharged.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eIncidence of early and late complications by anesthesia group.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMLA(n%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eGA(n%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eEB(n%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eP value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEarly complications\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003epain of perineum\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e88(14.9%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e14(11.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e24(13.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.548\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eurinary retention\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e84(14.2%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e36(29.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e54(29.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eFever\u0026thinsp;\u0026gt;\u0026thinsp;38\u0026deg;C\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e43(7.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e19(15.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e25(13.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.003\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eSepsis\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e10(1.7%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4(3.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2(1.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.381\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eHeadache or nausea\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e27(4.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e19(15.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e30(16.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eLate complications\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"4\" nameend=\"c5\" namest=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eurinary retention\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e50(8.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e16(13.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e23(12.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.125\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eFever\u0026thinsp;\u0026gt;\u0026thinsp;38\u0026deg;C\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e15(2.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e5(4.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e8(4.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.337\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eRehospitalization\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e2(0.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0(0.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1(0.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0.715\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eIn the MLA group, the overall PCa detection rate was 54.15% (320/591). The PCa detection rates for different PI-RADS scores were as follows: PI-RADS 3 was 34.3% (49/143), PI-RADS 4 was 53.5% (92/172), and PI-RADS 5 was 90.0% (153/170) (Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e). The PCa detection rates for PSA levels of \u0026lt;\u0026thinsp;10 ng/ml, 10\u0026ndash;20 ng/ml, and \u0026gt;\u0026thinsp;20 ng/ml were 39.0% (73/187), 41.1% (72/175), and 76.4% (175/229), respectively. Compared to previous literature, the detection rate in patients with PSA\u0026thinsp;\u0026lt;\u0026thinsp;10 ng/ml was slightly higher, while the detection rates for other PSA levels were consistent with previously reported ranges [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003ePCa detection rates in the MLA group stratified by PI-RADS score and PSA level.\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eDetection rate(n%)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMLA\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003ePrevious literature\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePSA(ng/ml)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;10\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e73/187(39.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e20%-30%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003e10\u0026ndash;20\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e72/175(41.1%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e32%-43%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003e\u0026gt;\u0026thinsp;20\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e175/229(76.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e56%-80%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePI-RADS\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003e3\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e49/143(34.3%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e30%-45%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003e4\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e92/172(53.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e47%-65%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003e5\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e153/170(90.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e83%-94%\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThis study demonstrates that our MLA protocol for prostate biopsy is a well-tolerated and safe alternative to GA and EB, offering significant advantages in reducing early postoperative complications without compromising diagnostic accuracy. Our findings support the adoption of MLA as a robust anesthetic strategy in routine clinical practice.\u003c/p\u003e\u003cp\u003eOur primary finding confirms that MLA is a well-tolerated procedure. Although the mean VAS score during anesthetic administration was statistically higher in the MLA group compared to the EB group (4.41 vs. 3.95), the absolute difference of less than 0.5 points on a 10-point scale is of limited clinical significance. More importantly, severe pain (VAS\u0026thinsp;\u0026ge;\u0026thinsp;7) was infrequent (3.89%), and no procedures were terminated due to discomfort, underscoring the clinical feasibility and high patient acceptance of this technique. Anecdotally, a high preference for MLA was reported by patients with prior biopsy experience under other anesthetic methods, further highlighting its excellent tolerability.\u003c/p\u003e\u003cp\u003eThe second major finding relates to the superior safety profile of MLA, particularly concerning early postoperative complications. The MLA group exhibited lower rates of urinary retention and fever compared to both GA and EB groups. The reduced incidence of urinary retention is a key advantage, likely attributable to the avoidance of prolonged motor and autonomic nerve blockade associated with EB and the bladder detrusor inhibition caused by systemic agents in GA. The lower fever rate may be multifactorial, potentially related to a shorter overall procedure time and a reduced systemic inflammatory response compared to more invasive anesthetic methods, a hypothesis that warrants further investigation.\u003c/p\u003e\u003cp\u003eCrucially, these improvements in safety and tolerability were not achieved at the expense of diagnostic efficacy. The overall prostate cancer detection rate in the MLA group (54.15%) was robust. When stratified by risk, the diagnostic yield was consistent with or even exceeded established benchmarks. For instance, the detection rate of 90.0% in patients with PI-RADS 5 lesions aligns well with the 83%-94% range reported in contemporary studies, and the 76.4% detection rate for PSA levels\u0026thinsp;\u0026gt;\u0026thinsp;20 ng/ml falls squarely within the expected 56%-80% range. Notably, our 39.0% detection rate in the low-PSA (\u0026lt;\u0026thinsp;10 ng/ml) subgroup is at the higher end of the typically reported 20%-30% range, which may suggest an enhanced sampling capability facilitated by the TP approach under MLA, although this requires further confirmation.\u003c/p\u003e\u003cp\u003eThe success of our protocol is rooted in the refined MLA technique itself. Unlike conventional single-point, superficial injections, our method employs a multi-point, layered infiltration strategy. It begins with a fan-shaped superficial block to numb the skin, followed by precise, ultrasound-guided deep infiltration at the prostatic apex and posterolateral aspects. This ensures comprehensive analgesia along the entire biopsy pathway, from the skin to the periprostatic nerves. This efficient technique not only enhances patient comfort but also streamlines the clinical workflow. The entire procedure takes only 12\u0026ndash;15 minutes and is more cost-effective as it obviates the need for an anesthesiologist and a formal operating room. Furthermore, as the operator's proficiency grew, we successfully omitted prophylactic antibiotics in the final 112 patients of the MLA cohort without any subsequent infectious complications. While preliminary, this promising observation suggests that antibiotic-free TP biopsy under MLA may be feasible, a significant advantage that warrants validation in future prospective trials.\u003c/p\u003e\u003cp\u003eOur findings contribute to the growing body of evidence supporting the shift from transrectal to transperineal biopsies to minimize infectious complications [\u003cspan additionalcitationids=\"CR14\" citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. We advocate for a freehand biopsy technique, which offers greater flexibility and cost-effectiveness over needle-guided probes, though we acknowledge it involves a learning curve, estimated at approximately 20 cases for a novice urologist to achieve proficiency.\u003c/p\u003e\u003cp\u003eThis study has several limitations that must be acknowledged. First, its single-center, retrospective, non-randomized design means that patient grouping was subject to clinical judgment and patient preference, potentially introducing selection bias. Second, all biopsies were performed by a single experienced urologist to ensure procedural consistency, which strengthens internal validity but may limit the generalizability of our findings to operators with varying levels of experience. Finally, the study lacked a direct comparison with TRUS biopsy.\u003c/p\u003e\u003cp\u003eTo build upon these promising findings, future research should prioritize large-scale, multi-center randomized controlled trials. Such trials are needed to confirm our results and should directly compare MLA with GA, EB, and TRUS approaches. These studies should incorporate formal non-inferiority testing for pain outcomes, a comprehensive cost-effectiveness analysis, and a structured evaluation of the learning curve for urologists new to the MLA technique.\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003eIn conclusion, this study provides robust evidence that TP biopsy under MLA is not only safe and well-tolerated but also superior to GA and EB in reducing early postoperative complications, such as fever and urinary retention. With comparable diagnostic accuracy, excellent patient acceptance, and potential for cost and resource savings, MLA is a suitable anesthetic option for transperineal prostate biopsy in routine clinical practice.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eTP\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Transperineal Prostate Biopsy\u003c/p\u003e\n\u003cp\u003eMLA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Modified Local Anesthesia\u003c/p\u003e\n\u003cp\u003eGA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;General Anesthesia\u003c/p\u003e\n\u003cp\u003eEB\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Epidural Block\u003c/p\u003e\n\u003cp\u003ePSA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Prostate-Specific Antigen\u003c/p\u003e\n\u003cp\u003eDRE\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Digital Rectal Examination\u003c/p\u003e\n\u003cp\u003eVAS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Visual Analog Scale\u003c/p\u003e\n\u003cp\u003ePCa\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Prostate Cancer\u003c/p\u003e\n\u003cp\u003eTRUS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Transrectal Ultrasound-guided Biopsy\u003c/p\u003e\n\u003cp\u003ePI-RADS \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Prostate Imaging Reporting and Data System\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics declaration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of The First Affiliated Hospital of Chongqing Medical University (Approval No. 2021-307). Written informed consent was obtained from all participants involved in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was sponsored by the National Natural Science Foundation of China to Fei Gao (No. 82370691). Furthermore, it was sponsored by Chongqing Science and Health Joint project (No.2020GDRC007), Senior Medical Talents Program of Chongqing for Yong and Middle-aged (No. 204216qn)\u0026nbsp;，\u0026nbsp;Reserve Talents Program for Academic Leaders of the First Affiliated Hospital of Chongqing Medical University (No. XKTS070) to Fei Gao. Finally, this work was also sponsored by Natural Science Foundation of Chongqing, China to Fei Gao (No. CSTB2023NSCQ-MSX0072) and Mei Yang(No. CSTB2023NSCQ- MSX0565).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthorship contribution statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization, Zhijie Jiang, Xin Yang, Linjie Li and Fei Gao; Data curation, Shiqi Yang, Xinyi Ling, Ge Wang and Xiaowen Huang; Formal analysis, Zhijie Jiang, Xin Yang and Linjie Li; Funding acquisition, Fei Gao; Investigation, Zhijie Jiang, Xin Yang and Linjie Li; Methodology, Zhijie Jiang, Xin Yang and Linjie Li; Project administration, Fei Gao; Resources, Fei Gao; Software, Zhijie Jiang, Xin Yang and Linjie Li; Supervision, Fei Gao; Validation, Zhijie Jiang, Xin Yang and Linjie Li; Writing \u0026ndash; original draft, Zhijie Jiang, Xin Yang and Linjie Li; Writing \u0026ndash; review \u0026amp; editing, Zhijie Jiang, Xin Yang, Linjie Li and Fei Gao.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data that support the findings of this study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe acknowledge all participants for their help in facilitating this research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient consent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eCulp, M. B., Soerjomataram, I., Efstathiou, J. A., Bray, F. \u0026amp; Jemal, A. Recent global patterns in prostate cancer incidence and mortality rates. \u003cem\u003eEur. Urol.\u003c/em\u003e \u003cb\u003e77\u003c/b\u003e, 38\u0026ndash;52 (2020).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eXia, C. et al. Cancer statistics in China and united states, 2022: Profiles, trends, and determinants. \u003cem\u003eChin. Med. J. (Engl)\u003c/em\u003e. \u003cb\u003e135\u003c/b\u003e, 584\u0026ndash;590 (2022).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChung, Y. \u0026amp; Hong, S. K. Evaluating prostate cancer diagnostic methods: The role and relevance of digital rectal examination in modern era. \u003cem\u003eInvestig Clin. Urol.\u003c/em\u003e \u003cb\u003e66\u003c/b\u003e, 181\u0026ndash;187 (2025).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eXiang, J. et al. Transperineal versus transrectal prostate biopsy in the diagnosis of prostate cancer: A systematic review and meta-analysis. \u003cem\u003eWorld J. Surg. Oncol.\u003c/em\u003e \u003cb\u003e17\u003c/b\u003e, 31 (2019).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLiss, M. A. et al. An update of the American urological association white paper on the prevention and treatment of the more common complications related to prostate biopsy. \u003cem\u003eJ. Urol.\u003c/em\u003e \u003cb\u003e198\u003c/b\u003e, 329\u0026ndash;334 (2017).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGrummet, J. P. et al. Sepsis and superbugs: Should we favour the transperineal over the transrectal approach for prostate biopsy? \u003cem\u003eBJU Int.\u003c/em\u003e \u003cb\u003e114\u003c/b\u003e, 384\u0026ndash;388 (2014).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSigle, A. et al. Evaluation of the ginsburg scheme: Where is significant prostate cancer missed? \u003cem\u003eCancers (Basel)\u003c/em\u003e. \u003cb\u003e13\u003c/b\u003e, 2502 (2021).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePepe, P. \u0026amp; Aragona, F. Prostate biopsy: Results and advantages of the transperineal approach\u0026ndash;twenty-year experience of a single center. \u003cem\u003eWorld J. Urol.\u003c/em\u003e \u003cb\u003e32\u003c/b\u003e, 373\u0026ndash;377 (2014).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRodriguez, A., Kyriakou, G., Leray, E., Lobel, B. \u0026amp; Guill\u0026eacute;, F. Prospective study comparing two methods of anaesthesia for prostate biopsies: Apex periprostatic nerve block versus intrarectal lidocaine gel: review of the literature. \u003cem\u003eEur. Urol.\u003c/em\u003e \u003cb\u003e44\u003c/b\u003e, 195\u0026ndash;200 (2003).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLu, D., Zhou, J., Cai, J., Liu, L. \u0026amp; Ni, Y. Clinical value of ultrasound-guided full-needle path anesthesia in transperineal prostate biopsy: An observational study. \u003cem\u003eMed. (Baltim).\u003c/em\u003e \u003cb\u003e103\u003c/b\u003e, e39008 (2024).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHjermstad, M. J. et al. Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: A systematic literature review. \u003cem\u003eJ. Pain Symptom Manage.\u003c/em\u003e \u003cb\u003e41\u003c/b\u003e, 1073\u0026ndash;1093 (2011).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKaufmann, B. et al. Prostate cancer detection rate in men undergoing transperineal template-guided saturation and targeted prostate biopsy. \u003cem\u003eProstate\u003c/em\u003e \u003cb\u003e82\u003c/b\u003e, 388\u0026ndash;396 (2022).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKum, F. et al. Initial outcomes of local anaesthetic freehand transperineal prostate biopsies in the outpatient setting. \u003cem\u003eBJU Int.\u003c/em\u003e \u003cb\u003e125\u003c/b\u003e, 244\u0026ndash;252 (2020).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMarra, G. et al. Transperineal freehand multiparametric MRI fusion targeted biopsies under local anaesthesia for prostate cancer diagnosis: A multicentre prospective study of 1014 cases. \u003cem\u003eBJU Int.\u003c/em\u003e \u003cb\u003e127\u003c/b\u003e, 122\u0026ndash;130 (2021).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLopez, J. F. et al. Local anaesthetic transperineal (LATP) prostate biopsy using a probe-mounted transperineal access system: A multicentre prospective outcome analysis. \u003cem\u003eBJU Int.\u003c/em\u003e \u003cb\u003e128\u003c/b\u003e, 311\u0026ndash;318 (2021).\u003c/span\u003e\u003c/li\u003e\u003c/ol\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":"Transperineal Prostate Biopsy, Prostate Cancer, Modified Local Anesthesia, Pain, Diagnosis","lastPublishedDoi":"10.21203/rs.3.rs-7813031/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7813031/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eTo evaluate the safety and tolerability of a modified local anesthesia (MLA) protocol for transperineal (TP) prostate biopsy and to compare its outcomes with general anesthesia (GA) and epidural block (EB)..\u003c/p\u003e\u003ch2\u003ePatients and Methods:\u003c/h2\u003e\u003cp\u003eThis retrospective study analyzed 897 patients who underwent TP prostate biopsy between January 2021 and July 2024, all performed by the same experienced urologist. Patients were divided into three groups: MLA (n\u0026thinsp;=\u0026thinsp;591), GA (n\u0026thinsp;=\u0026thinsp;123), or EB (n\u0026thinsp;=\u0026thinsp;183). Key metrics for evaluating safety and tolerability included the visual analog scale (VAS) for pain, incidence of complications, and the cancer detection rate.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eA total of 897 patients were analyzed (591 MLA, 123 GA, 183 EB). While the MLA group reported higher pain scores during anesthesia administration compared to the EB group (mean VAS 4.41 vs. 3.95, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), severe pain (VAS\u0026thinsp;\u0026ge;\u0026thinsp;7) was infrequent (3.89%). Notably, the MLA group exhibited a lower incidence of early complications, including urinary retention (14.2% vs. 29.3% in GA and 29.5% in EB, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) and fever (7.3% vs. 15.4% in GA and 13.7% in EB, p\u0026thinsp;=\u0026thinsp;0.003). The overall prostate cancer (PCa) detection rate in the MLA group was 54.15%, indicating comparable diagnostic efficacy.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eMLA for TP biopsy is a safe and well-tolerated procedure that reduces early postoperative complications compared to GA and EB, while maintaining high diagnostic accuracy. Therefore, MLA represents a robust alternative anesthetic strategy, offering a balance between patient comfort, safety, and clinical efficiency.\u003c/p\u003e","manuscriptTitle":"Modified Local Anesthesia for Transperineal Prostate Biopsy: A Comparative Study of Safety and Tolerability","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-01 08:10:42","doi":"10.21203/rs.3.rs-7813031/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":"870febd1-db6a-4daf-abcf-80c4245a84dd","owner":[],"postedDate":"December 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":58735738,"name":"Biological sciences/Cancer"},{"id":58735739,"name":"Health sciences/Diseases"},{"id":58735740,"name":"Health sciences/Medical research"},{"id":58735741,"name":"Health sciences/Oncology"},{"id":58735742,"name":"Health sciences/Urology"}],"tags":[],"updatedAt":"2025-12-02T11:08:51+00:00","versionOfRecord":[],"versionCreatedAt":"2025-12-01 08:10:42","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7813031","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7813031","identity":"rs-7813031","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}