Ultrasound-guided bilateral TAP block versus local bupivacaine infiltration for pain after unilateral laparoscopic TEP inguinal hernia repair
Comparison of Postoperative Analgesic Efficacy of Ultrasonographic Bilateral TAP (Transversus Abdominis Plane) Block and Anesthetic Infiltration Into Preperitoneal and the Surgical Field in Laparoscopic Unilateral TEP (Total Extraperitoneal) Herniorraphy
This trial will test whether an ultrasound-guided bilateral TAP block or local bupivacaine infiltration provides better pain relief after unilateral laparoscopic TEP inguinal hernia repair in adults aged 18–65.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Başakşehir Çam & Sakura City Hospital Government |
| Locations | 1 site (Başakşehir, Istanbul) |
| Trial ID | NCT06894420 on ClinicalTrials.gov |
What this trial studies
This prospective, randomized trial will enroll 60 adult patients undergoing unilateral laparoscopic total extraperitoneal (TEP) inguinal herniorrhaphy and randomly assign them to two groups. Group I will receive preperitoneal and surgical-site infiltration with bupivacaine, while Group II will receive ultrasound-guided bilateral transversus abdominis plane (TAP) blocks with bupivacaine. The primary outcomes are postoperative pain scores using the visual analog scale (VAS) and additional analgesic requirements; secondary outcomes include length of postoperative hospital stay and cost-effectiveness. Demographic data, ASA scores, comorbidities, and operation times will be recorded and compared between groups.
Who should consider this trial
Good fit: Ideal candidates are consenting adults aged 18–65 with unilateral inguinal hernia, ASA I–II, planned for elective laparoscopic TEP repair, without prior lower abdominal incisions or hernia surgery and not taking anticoagulant/antiaggregant drugs.
Not a fit: Patients with contraindications to regional anesthesia, open or bilateral hernia repairs, strangulated hernia, significant uncontrolled chronic disease (e.g., uncontrolled diabetes or hypertension), chronic opioid/analgesic use, or who are taking anticoagulants are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the preferred approach could reduce postoperative pain and opioid use and possibly shorten hospital stay after laparoscopic TEP hernia repair.
How similar studies have performed: Previous studies have shown that both TAP blocks and local anesthetic infiltration can reduce postoperative abdominal wall pain, but head-to-head comparisons in laparoscopic TEP herniorrhaphy are limited and have produced mixed results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consenting patients, * She will undergo laparoscopic hernia repair surgery, * ASA-I-II, * Between the ages of 18 and 65, * No history of anticoagulant or antiaggregant drug use, * Regional anesthesia is not contraindicated and the anesthesiologist deems -appropriate for regional anesthesia, * Under general anesthesia and will undergo laparoscopic surgery, * Fully oriented and cooperative, * Unilateral inguinal hernia, * No previous surgery for inguinal hernia, * No incision in the lower abdomen, * Not using alcohol and drugs, * No preoperative pain and * Patients without symptoms of strangulated hernia will be included in the study. Exclusion Criteria: * Patients without consent * Regional anesthesia is contraindicated, * Those who will undergo open abdominal surgery, * Not in the appropriate age range, * Chronic diseases such as uncontrolled DM and HT, * Drug allergy, * Taking anticoagulant or antiaggregant drugs, * History of chronic analgesic use, * Presence of active infection in the area to be blocked, * Will not be able to comply with postoperative pain /VAS follow-up, * Patients with ASA-III-IV, * Patients with bilateral inguinal and scrotal hernias, * Patients who have been previously operated for inguinal hernia and have an incision in the lower abdomen, * Those with a history of alcohol and drug abuse * Preoperative pain and * Those with symptoms of strangulated hernia will not be included in this study.
Where this trial is running
Başakşehir, Istanbul
- Başakşehir Çam ve Sakura Şehir Hastanesi — Başakşehir, Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ali Bekraki, Principal Investigator
- Email: abekraki@hotmail.com
- Phone: +905372437699
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.