Transversus Abdominis Plane Lock Versus Quadratus Lumborum Block in Children

March 2, 2025 updated by: Mehdi Trifa, Tunis University

Pediatric Transversus Abdominis Plane Block Versus Quadratus Lumborum Block: a Prospective Randomized Study in Sub-umbilical Peripheral Surgery

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

90

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 Locations

      • Tunis, Tunisia, 1029
        • Bechir Hamza Children's 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:

  • 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 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAP block group
Ultrasound-guided TAP block group
The operator applied a linear ultrasound probe transversally to the mid-axillary line between the costal margin and iliac crest. Landmarks were then identified as three muscles layers beneath the subcutaneous tissue; from external to internal lay respectively the external oblique muscle (EO), the internal oblique muscle (IO) and the transversus abdominis (TA). The needle was inserted in plane from the iliac crest level on the midaxillary line advancing towards the midline to the fascia laying between the IO and the TA muscles until pop detection. A clear aspiration ruled out vascular effraction. Finally, the space between the two muscle planes was hydrodissected with the bupivacaine.The end goal was visualizing the IO moving upward leaving room to a hypoechoic lens-shaped local anesthetic distribution.
Active Comparator: QLB block group
Ultrasound-guided Quadratus Lumborum block group
The patient was laid in a lateral decubitus position. The operator applied the probe transversally on the iliac crest directing the indicator to display the back muscles encompassed by the thoracolumbar fascia (TLF).The intended image was spotted by the emergence of the transverse process L4, delimiting the stem of a shamrock-like shape. Quadratus lumborum (QL) muscle represented the upper leaf of the shamrock, and psoas major (PM) and erector spinae (ES) stood respectively for the anterior and posterior leaves. The needle was inserted in plane from the postero-median lumbar wall directed antero-laterally with tip aiming at the posterior border of the QL muscle adjacent to the ES muscles. Pop detection indicated the middle TLF where the local anesthetic would spread, homogenous and resistance-free

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first rescue analgesia
Time Frame: 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)
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
block Failure rate
Time Frame: 30 minutes
percentage of failed blocks in both groups
30 minutes
FLACC scale pain scores
Time Frame: 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

2 hours
PPMP scale scores
Time Frame: 24 hours
Parents' Postoperative Pain Measure scores after discharge (at H6, H12, and H24 post operative).
24 hours
Total analgesic consumption
Time Frame: 24 hours
determined by the total number of rescue paracetamol doses administered (mg per kilogram of weight)
24 hours
Post operative nausea and vomiting (PONV)
Time Frame: 24 hours
incidence (percentage) of post operative nausea and vomiting in both groups
24 hours
Urinary retention
Time Frame: 24 hours
incidence (percentage) of post operative Urinary retention in both groups
24 hours

Collaborators and Investigators

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

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 (Actual)

October 1, 2022

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

March 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 2, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

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.

Clinical Trials on Post Operative Analgesia

Clinical Trials on Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25%

Subscribe