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Recruiting NCT07540689

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

No phase Interventional Post Operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: port site infiltration, M-TAPA.
Who it may be relevant to
Registry conditions: Post Operative Pain. Basic parameters: 1 year — 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • FLACC pain score [Time frame: 6 hours postoperatively.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Egypt · 1 center
  • Kasralainy Hospital — Cairo

Identifiers

NCT: NCT07540689 · MD-402-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗