Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block (TAP) and Modified Thoracoabdominal Nerve Block (M-TAPA)

June 3, 2025 updated by: Muruvvet Taskir Turan, Ankara Etlik City Hospital

Comparison of Postoperative Analgesic Efficacy of Transversus Abdominis Plane Block (TAP) and Modified Thoracoabdominal Nerve Block (M-TAPA) in Patients Undergoing Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy is a frequently performed surgical procedure and is considered the gold standard for treating symptomatic gallstone disease. Although laparoscopic cholecystectomy is considered minimally invasive, it can cause moderate to severe pain in the postoperative period. Poorly controlled early postoperative pain can impair recovery quality and increase the risk of postoperative pulmonary complications as a risk factor for chronic pain development. Multimodal analgesia, including opioids, is used to limit pain following laparoscopic cholecystectomy. However, opioid treatment may lead to side effects such as postoperative nausea and vomiting (PONV), respiratory depression, and constipation.

Nerve blocks provide better pain control, reduce opioid consumption in the postoperative period, and offer advantages such as fewer side effects and a lower risk of pulmonary and cardiac complications.

In our clinic, a multimodal analgesia approach is preferred for patients undergoing laparoscopic cholecystectomy. In addition to intravenous analgesic agents, peripheral nerve blocks are administered based on patient preference (for all eligible and consenting patients).

This study aims to compare the postoperative analgesic efficacy of the Transversus Abdominis Plane (TAP) Block and the Modified Thoracoabdominal Nerve Block with a Pericostal Approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. Standard analgesic methods are applied to patients who do not consent to peripheral nerve block administration.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ankara
      • Yenimahalle, Ankara, Turkey, 06170
        • Recruiting
        • Ankara Etlik City Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 65 years old
  • American Society of Anesthesiologists (ASA) physical status I-II-III
  • Body mass index 18 to 30 kg/m2
  • Elective laparoscopic cholecystectomy surgery

Exclusion Criteria:

  • Under 18 and over 65
  • ASA score IV and above
  • Advanced co-morbidity
  • History of bleeding diathesis
  • Patient refusing the procedure
  • Chronic opioid or analgesic use
  • Patients who will operate under emergency conditions
  • Block injection site infection
  • Known allergy to local anesthetics
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transversus Abdominis Plane (TAP) Block
The patient is placed in the supine position,the injection site is disinfected.The Transversus Abdominis Plane block is performed under ultrasound guidance using a high-frequency linear probe(6-13 MHz)placed sagittally at the midpoint between the costal margin and the iliac crest.On ultrasound, the skin, subcutaneous fat tissue, external oblique muscle, internal oblique muscle, and transversus abdominis muscle are visualized. A 2G, 80 mm block needle is inserted in the same plane as the ultrasound probe.As the needle passes through the muscle layers and fascial planes, a fascial "click" sensation is felt, and the needle tip is advanced under ultrasound guidance in a controlled manner.After the second "click" sensation(the passage through the internal oblique muscle fascia) a test dose of 1 mL is administered to confirm needle tip localization.Once the location is verified, 20 mL of 0.25% bupivacaine is injected into the neurofascial plane. then repeated on the contralateral side.
Transversus Abdominis Plane (TAP) Block is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position.
Active Comparator: Modified Thoracoabdominal Nerve Block (M-TAPA)
The patient is placed in the supine position, and the injection site is disinfected.Modified Thoracoabdominal Nerve Block To identify the transversus abdominis, internal oblique and external oblique muscles a high-frequency linear ultrasound probe (6-13 MHz) is placed sagittally at the 10th costal margin under USG guidance.After positioning the probe sagittally at the 10th costal margin in the midline, it is angled deeply toward the costochondral angle to visualize the lower costal cartilage.Using an in-plane technique, a 22G, 80 mm block needle is inserted in a cranial direction between the transversus abdominis muscle and the lower surface of the costal cartilage. The needle tip is advanced toward the posterior surface of the 10th costal cartilage, and 20 mL of 0.25% bupivacaine is injected beneath the chondrium while ensuring that the needle tip does not pass beyond the cranial border of the 10th costal cartilage. The same procedure is then repeated on the contralateral side.
Modified Thoracoabdominal Nerve Block (M-TAPA) is performed under ultrasound guidance before the surgical procedure and anesthesia induction, with the patient in the supine position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: First 24 hours after surgery
Pain will be assessed at rest and while movement using the from 0 (no pain) to 10 (worst
First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative remifentanil consumption
Time Frame: During The intraoperatif period
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded
During The intraoperatif period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

April 11, 2026

Study Completion (Estimated)

April 21, 2026

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • AEŞH-EK-2025-043

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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