Clinical trial NCT06861556: Transversus Abdominis Plane Lock Versus Quadratus Lumborum Block in Children
Official title: Pediatric Transversus Abdominis Plane Block Versus Quadratus Lumborum Block: a Prospective Randomized Study in Sub-umbilical Peripheral Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nerve Block
Post Operative Analgesia
Ultrasound-guided Regional Anesthesia
Keywords: Transversus Abdominis Plane block
QUADRATUS LUMBORUM BLOCK
post operative analgesia
Ultrasound
Children
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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%
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Time to first rescue analgesia
timeFrame: 3 hours
Secondary outcomes:
measure: block Failure rate
timeFrame: 30 minutes
measure: FLACC scale pain scores
timeFrame: 2 hours
measure: PPMP scale scores
timeFrame: 24 hours
measure: Total analgesic consumption
timeFrame: 24 hours
measure: Post operative nausea and vomiting (PONV)
timeFrame: 24 hours
measure: Urinary retention
timeFrame: 24 hours
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Bechir Hamza Children's Hospital
Study officials:
References: