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TAPB vs. Caudal for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial

Phase 4
Completed
Conditions
Anesthesia, Recovery Period
Interventions
Procedure: Transversus Abdominis Plane Block
Procedure: Caudal Epidural
Registration Number
NCT02160821
Lead Sponsor
Nemours Children's Clinic
Brief Summary

Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.

Detailed Description

The study design was a double-blinded randomized controlled trial. A minimum of 44 children between the ages of 1 and 9 undergoing bilateral ureteral reimplantation surgery through a low transverse incision will be enrolled. Narcotic requirement, pain scores (FLACC/FACES), episodes of nausea/vomiting, and anti-spasmodic requirement will be recorded in the PACU and at 6 hour intervals through 24 hours from the time of the block placement.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
Inclusion Criteria
  • Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery
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Exclusion Criteria
  1. Coagulation status or anatomic variations precluded safe placement of either TAPB or caudal epidural,
  2. there was a preexisting chronic pain disorder,
  3. there was a history of constipation that persisted despite appropriate treatment and that may have impacted postoperative pain assessments,
  4. additional procedures were planned via a separate incision at the time of the ureteral reimplantation, 5) there was a contraindication to receiving the medications described in the protocol.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Transversus Abdominis Plane BlockTransversus Abdominis Plane BlockTransversus Abdominis Plane Block TAPB Ultrasound guided TAPB
Caudal Epidural BlockCaudal EpiduralCaudal Epidural Block Caudal Block Neuraxial Block Ultrasound Guided Caudal Block
Primary Outcome Measures
NameTimeMethod
Narcotic requirement24 hours post intervention

Narcotic requirement was recorded at 24 hours from the time of the block placement.

Secondary Outcome Measures
NameTimeMethod
episodes of nausea/vomiting24 hours

Episodes of nausea/vomiting were recorded at 24 hours from the time of the block placement.

Pain Scores24 hours post intervention

Pain scores (FLACC/FACES) were recorded at 24 hours from the time of the block placement

anti-spasmodic requirement24 hours post intervention

Anti-spasmodic requirement were recorded at 24 hours from the time of the block placement.

Trial Locations

Locations (1)

Wolfson Children's Hospital, Baptist Medical Center- Downtown, 800 Prudential Drive

🇺🇸

Jacksonville, Florida, United States

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