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Completed

NCT Number: NCT06861556

Transversus Abdominis Plane Lock Versus Quadratus Lumborum Block in Children

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.

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Key information

Conditions

Peripheral Nerve Block Post Operative Analgesia Ultrasound-guided Regional Anesthesia

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bechir Hamza Children's Hospital

Tunis, 1029, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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.

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

Procedure

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. block Failure rate

    Time frame: 30 minutes

    percentage of failed blocks in both groups

  2. 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

  3. PPMP scale scores

    Time frame: 24 hours

    Parents' Postoperative Pain Measure scores after discharge (at H6, H12, and H24 post operative).

  4. Total analgesic consumption

    Time frame: 24 hours

    determined by the total number of rescue paracetamol doses administered (mg per kilogram of weight)

  5. Post operative nausea and vomiting (PONV)

    Time frame: 24 hours

    incidence (percentage) of post operative nausea and vomiting in both groups

  6. Urinary retention

    Time frame: 24 hours

    incidence (percentage) of post operative Urinary retention in both groups

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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