NCT07540689

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Apr 2027

First Submitted

Initial submission to the registry

April 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 14, 2026

Last Update Submit

April 20, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • FLACC pain score

    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.

Study Arms (2)

port site infiltration

ACTIVE COMPARATOR

Children will receive port site LA infiltration.

Procedure: port site infiltration

M-TAPA

ACTIVE COMPARATOR

Children will receive bilaterall ultrasound guided M-TAPA block.

Procedure: M-TAPA

Interventions

children will receive port site LA infiltration.

port site infiltration
M-TAPAPROCEDURE

Children will receive bilateral M-TAPA regional anesthesia block.

M-TAPA

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasralainy Hospital

Cairo, Elmanial, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Ahmed M Elhaddad, Ass.prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstent Professor

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations