Transversus Abdominis Plane Lock Versus Quadratus Lumborum Block in Children

Not Applicable

Completed

• Conditions: Peripheral Nerve Block; Post Operative Analgesia; Ultrasound-guided Regional Anesthesia

• Registration Number: NCT06861556
• Lead Sponsor: Tunis University

Brief Summary

Although abdominal wall surgeries are also as routinely performed on pediatric patients, postoperative pain in children has remained under-researched compared to adults. Consequently, there has been a growing need for adapting regional analgesia to this distinct population. While the Transversus Abdominis Plane Block (TAPB) and Quadratus Lumborum Block (QLB) have been established as potent sensory blocks in adult practice, data on their efficiency in pediatric abdominal parietal surgeries remain scarce.

The investigators aimed to compare the analgesic effect of lateral TAPB versus posterior QLB in children undergoing elective abdominal wall surgery.

Detailed Description

Randomized controlled trial, including pediatric patients aged from 1 to 10 years old scheduled for an elective outpatient open sub-umbilical abdominal wall surgery.

After a standardized anesthesia induction protocol, patients were randomized into two parallel groups receiving either a lateral TAPB or a posterior QLB.

The investigators determined the time to first rescue analgesia as the primary outcome of the present trial. As for secondary outcomes, the investigators set out to comparatively assess block failure rates, intra operative hemodynamic features pain scores consisting of FLACC scale values, analgesic consumption attested by the number of administrated rescue paracetamol doses along the cumulative administered dose per kilogram of weight within the first postoperative 24 hours, as well as the incidence of side effects namely systemic local anesthetic toxicity symptoms, PONV, urinary retention, ICU admission or re-intervention for block-related complications.

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-06-28
• Study First Submitted: 2024-11-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-02
• Last Update Submitted: 2025-03-02
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• We included patients aged from 1 to 10 years old with American Society of Anesthesiologists (ASA) physical status I or II.

Exclusion Criteria

• Non-inclusion criteria were a priorly known allergy to local anesthetics, a priorly known or suspected coagulopathy, inflammation or infection at the needle injection site, cognitive impairment preventing standard pain assessment and associated circumcision or scrotal incision.
• Later on after allocation, patients were excluded for block failure or major perioperative complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to first rescue analgesia	3 hours	Time (in minutes) from the completion of the block to first analgesia administration based on postoperative pain score (assessed using FLACC (Face Legs Activity Crying Consolability) in ward \>3)

Secondary Outcome Measures

Name	Time	Method
block Failure rate	30 minutes	percentage of failed blocks in both groups
FLACC scale pain scores	2 hours	Post operative analgesia was assessed using the following measures: - pain scores including the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, recorded at H0, H1, H2
PPMP scale scores	24 hours	Parents' Postoperative Pain Measure scores after discharge (at H6, H12, and H24 post operative).
Total analgesic consumption	24 hours	determined by the total number of rescue paracetamol doses administered (mg per kilogram of weight)
Post operative nausea and vomiting (PONV)	24 hours	incidence (percentage) of post operative nausea and vomiting in both groups
Urinary retention	24 hours	incidence (percentage) of post operative Urinary retention in both groups

Trial Locations

Locations (1)

Bechir Hamza Children's Hospital; 🇹🇳 Tunis, Tunisia