NCT06861556

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

November 24, 2024

Last Update Submit

March 2, 2025

Conditions

Keywords

Transversus Abdominis Plane blockQUADRATUS LUMBORUM BLOCKpost operative analgesiaUltrasoundChildren

Outcome Measures

Primary Outcomes (1)

  • Time to first rescue analgesia

    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 Outcomes (6)

  • block Failure rate

    30 minutes

  • FLACC scale pain scores

    2 hours

  • PPMP scale scores

    24 hours

  • Total analgesic consumption

    24 hours

  • Post operative nausea and vomiting (PONV)

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

TAP block group

ACTIVE COMPARATOR

Ultrasound-guided TAP block group

Procedure: Ultrasound guided Transversus Abdominis Plane block with 0.2ml/kg bupivacaine 0.25%

QLB block group

ACTIVE COMPARATOR

Ultrasound-guided Quadratus Lumborum block group

Procedure: Ultrasound-guided Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%

Interventions

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.

TAP 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

QLB block group

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Later on after allocation, patients were excluded for block failure or major perioperative complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bechir Hamza Children's Hospital

Tunis, 1029, Tunisia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The patients were randomly assigned into two groups to receive after a standardized general anesthesia induction either an ultrasound-guided TAP block or Quadratus Lumborum block with 0.2ml/kg bupivacaine 0.25%
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Anesthesiology and Intensive Care, head chief of the department of Anesthesia and Intensive Care

Study Record Dates

First Submitted

November 24, 2024

First Posted

March 6, 2025

Study Start

October 1, 2022

Primary Completion

March 31, 2023

Study Completion

June 28, 2023

Last Updated

March 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations