The Analgesic Efficacy of M-TAPA for Laparoscopic Abdominal Surgery in Children (M-TAPA)

April 20, 2026 updated by: Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital

The Analgesic Efficacy of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Laparoscopic Abdominal Surgery in Children: Randomized Controlled Trial

This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.

Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to receive either port-site local anesthetic infiltration or M-TAPA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.

Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to a port site local anesthetic infiltration. or M-TAPA.

  1. port-site local anesthetic infiltration Before the skin incision, the surgeon will inject 0.17 mL/kg of 0.25% bupivacaine (up to 2 mg/kg) via infiltration into the skin, subcutaneous tissue, and muscle fascia at the three laparoscopic ports.
  2. M-TAPA. Before skin incision, Ultrasound will be used to perform bilateral M-TAPA.0.25 mL/kg of 0.25% bupivacaine will be administered at each side.

Study Type

Interventional

Enrollment (Estimated)

60

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 Locations

  • Egypt
    • Elmanial
      • Cairo, Elmanial, Egypt, 11562
        • Recruiting
        • Kasralainy Hospital

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age (1-7) years.
  • Both genders.
  • American Society of Anaesthesiologists (ASA) - physical status I-II.
  • Children undergoing elective laparoscopic abdominal surgery.

Exclusion Criteria:

  • Parental refusal.
  • Bleeding disorders with INR > 1.5 and/or platelets < 50 000.
  • History of allergic reactions to local anesthetics.
  • Rash or signs of infection at the injection site.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: port site infiltration
Children will receive port site LA infiltration.
Procedure: port site infiltration
children will receive port site LA infiltration.
Active Comparator: M-TAPA
Children will receive bilaterall ultrasound guided M-TAPA block.
Procedure: M-TAPA
Children will receive bilateral M-TAPA regional anesthesia block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FLACC pain score
Time Frame: 6 hours postoperatively.
The FLACC (Face, Leg, Activity, Cry, Consolability) pain score ( Each category is scored on a 0-2 scale, which results in a total score of 0-10 0:comfortable, 1-3: mild discomfort, 4-6: moderate discomfort, & 7-10: severe discomfort ) (FLACC) scale pain score at 6 hours.
6 hours postoperatively.

Collaborators and Investigators

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

Sponsor

Kasr El Aini Hospital

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 (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-402-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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