Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06894420

Comparison of Postoperative Analgesic Efficacy of Ultrasonographic Bilateral TAP Block and Anesthetic Infiltration Into Preperitoneal and Surgical Field in Laparoscopic Unilateral TEP Herniorrhaphy

Led by Başakşehir Çam & Sakura City Hospital · Updated on 2025-09-24

60

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two pain management methods for patients undergoing laparoscopic unilateral total extraperitoneal (TEP) inguinal hernia repair. This randomized study compares preperitoneal and surgical site anesthetic infiltration with ultrasound-guided bilateral transversus abdominis plane (TAP) block. The goal is to identify the best approach for reducing postoperative pain and improving patient comfort after this common surgical procedure. Participants will be randomly assigned to one of two groups. Group-I will receive infiltration with bupivacaine into the preperitoneal space and trocar incision sites during surgery. Group-II will receive an ultrasound-guided bilateral TAP block with bupivacaine administered by an anesthesiologist after surgery but before waking up. Both groups will receive general anesthesia during surgery, and postoperative pain will be managed with paracetamol and NSAIDs. Rescue analgesia with intravenous paracetamol will be available if needed. Participants will be monitored for postoperative pain using the visual analog scale (VAS) within the first 24 hours after surgery. Additional analgesic requirements, hospital stay duration, and cost-effectiveness will also be recorded. Demographic data, ASA scores, comorbidities, and operation times will be collected. Statistical analysis will compare pain outcomes between groups to determine the optimal pain control method. The total study duration includes surgery, immediate postoperative monitoring, and follow-up assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Consenting patients
  • Scheduled for laparoscopic hernia repair surgery
  • ASA physical status I or II
  • Aged between 18 and 65 years
  • No history of anticoagulant or antiaggregant drug use
  • Suitable for regional anesthesia as determined by anesthesiologist
  • Undergoing general anesthesia for laparoscopic surgery
  • Fully oriented and cooperative
  • Unilateral inguinal hernia diagnosis
  • No previous surgery for inguinal hernia
  • No incision in the lower abdomen
  • Not using alcohol or drugs
  • No preoperative pain
  • No symptoms of strangulated hernia
Not Eligible

You will not qualify if you...

  • Lack of consent
  • Contraindication to regional anesthesia
  • Undergoing open abdominal surgery
  • Outside the age range of 18 to 65 years
  • Chronic uncontrolled diseases such as diabetes mellitus or hypertension
  • Drug allergy
  • Taking anticoagulant or antiaggregant drugs
  • History of chronic analgesic use
  • Active infection at the site to be blocked
  • Unable to comply with postoperative pain or VAS follow-up
  • ASA physical status III or IV
  • Bilateral inguinal or scrotal hernias
  • Previous inguinal hernia surgery with lower abdominal incision
  • History of alcohol or drug abuse
  • Preoperative pain
  • Symptoms of strangulated hernia not included in study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo laparoscopic unilateral TEP hernia repair under general anesthesia with either local anesthetic infiltration into the surgical field or bilateral ultrasound-guided TAP block for postoperative pain management.

1 surgery visit (in-person)

Postoperative Follow-up

Duration - 24 hours after surgery

Participants are monitored for postoperative pain and analgesic needs within 24 hours after surgery using pain scores and additional pain medication if required.

1 follow-up visit (in-person) within 24 hours

Trial Site Locations

Total: 1 location

1

Başakşehir Çam ve Sakura Şehir Hastanesi

Başakşehir, Istanbul, Turkey (Türkiye), 34480

Actively Recruiting

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Research Team

A

Ali Bekraki, Principal Investigator

Y

Yunus Fırat Emekli, Research Assistant

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Laparoscopic-assisted transversus abdominis plane block as an effective analgesic in total extraperitoneal inguinal hernia repair: a double-blind, randomized controlled trial.

A Mughal, A Khan, J Rehman...

https://pubmed.ncbi.nlm.nih.gov/30173291

Infiltration of bupivacaine into the preperitoneal space and trocar incisions of patients undergoing laparoscopic totally extraperitoneal repair of unilateral inguinal hernia: a prospective randomized controlled observational study.

Şükrü Çolak, Önder Akkuş, Bünyamin Gürbulak...

https://pubmed.ncbi.nlm.nih.gov/32117481

Ultrasound-versus visual-guided transversus abdominis plane block prior to transabdominal preperitoneal ingunial hernia repair. A retrospective cohort study.

C Paasch, J Fiebelkorn, G De Santo...

https://pubmed.ncbi.nlm.nih.gov/33133582

The analgesic efficacy of transversus abdominis plane block vs. wound infiltration after inguinal and infra-umbilical hernia repairs: A systematic review and meta-analysis with trial sequential analysis.

Sina Grape, Kyle R Kirkham, Eric Albrecht

https://pubmed.ncbi.nlm.nih.gov/35131973

Cutaneous sensory block area of the laparoscopic-assisted transversus abdominis plane block.

Christopher Blom Salmonsen, Kai Henrik Wiborg Lange, Christian Rothe...

https://pubmed.ncbi.nlm.nih.gov/39323259