Clinical Trial

Comparison the Analgesic Efficacy of Ultrasonographic Bilateral TAP and Anesthetic Infiltration Into the Surgery Field for Laparoscopic Unilateral TEP Herniorrhaphy

Completed
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Summary
Laparoscopic inguinal hernia repair is a common surgical procedure, but postoperative pain management remains a challenge. This prospective, randomized study aims to compare the analgesic efficacy of preperitoneal and surgical site anesthetic infiltration with ultrasound-guided bilateral transversus abdominis plane (TAP) block in patients undergoing laparoscopic unilateral total extraperitoneal (TEP) herniorrhaphy. Sixty patients will be randomly allocated into two groups: Group-I will receive preperitoneal and surgical site infiltration with bupivacaine, while Group-II will receive ultrasound-guided bilateral TAP block with bupivacaine. The primary outcomes will be postoperative pain scores assessed using the visual analog scale (VAS) and additional analgesic requirements. Secondary outcomes will include postoperative hospital stay duration and cost-effectiveness. Demographic data, ASA scores, comorbidities, and operation times will be recorded. Postoperative pain will be managed with a multimodal approach, including paracetamol and NSAIDs. Rescue analgesia will be provided with intravenous paracetamol. Statistical analysis will be performed using t-tests, ANOVA, Wilcoxon-Mann-Whitney tests, and chi-square tests, as appropriate. This study aims to determine the optimal and most beneficial method for postoperative pain management and patient comfort following laparoscopic inguinal hernia repair.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2025-03-24; most recent amendment 2026-07-21.
Status change: Recruiting → Completed 2026-07-21
Status change: Not Yet Recruiting → Recruiting 2025-09-19
Trial Details
NCT Number NCT06894420
Lead Sponsor Başakşehir Çam & Sakura City Hospital
Conditions Laparoscopic Surgery, Herniorrhaphy, Inguinal Hernia Unilateral, Transversus Abdominis Plane (TAP) Block, Postoperative Analgesia
Enrollment 60 participants
Start Date 2025-09-04
Primary Completion 2026-04-20 (estimated)
Study Completion 2026-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-22