Transversus Abdominis Plane Lock Versus Quadratus Lumborum Block in Children

NCT ID: NCT06861556

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-06-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TAP block group

Ultrasound-guided TAP block group

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

QLB block group

Ultrasound-guided Quadratus Lumborum block group

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

Interventions

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

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.

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tunis University

OTHER

Sponsor Role: lead

Responsible Party

Mehdi Trifa

Full Professor of Anesthesiology and Intensive Care, head chief of the department of Anesthesia and Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bechir Hamza Children's Hospital

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

222022

Identifier Type: -

Identifier Source: org_study_id