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

NCT07540689 — Not applicable, Recruiting, 60 participants, Kasr El Aini Hospital

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

Registry	NCT07540689, acronym M-TAPA
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, supportive care
Enrollment	60 (Estimated)
Sponsor	Kasr El Aini Hospital (Other)
Conditions	Post Operative Pain
Interventions	port site infiltration, M-TAPA (Procedure)
Dates	start 2026-05-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-04-01 (estimated), first posted 2026-04-20, last updated 2026-04-23
Locations	1 site in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
port site infiltration	Active comparator	Procedure: port site infiltration	Children will receive port site LA infiltration.
M-TAPA	Active comparator	Procedure: M-TAPA	Children will receive bilaterall ultrasound guided M-TAPA block.

port site infiltration (Procedure): children will receive port site LA infiltration.
M-TAPA (Procedure): Children will receive bilateral M-TAPA regional anesthesia block.

+Outcome measures

Primary outcomes

FLACC pain score [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.

+Eligibility

Sex: All, ages: 1 Year to 7 Years

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.

+Locations (1)

Facility	City	Country	Status
Kasralainy Hospital	Cairo, Elmanial	Egypt	Recruiting