Clinical Trials Directory

Trials / Completed

CompletedNCT02160821

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

Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Nemours Children's Clinic · Academic / Other
Sex
All
Age
1 Year – 9 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURECaudal EpiduralUltrasound Guided Caudal Block
PROCEDURETransversus Abdominis Plane BlockUltrasound Guided Transversus Abdominis Plane Block

Timeline

Start date
2011-01-01
Primary completion
2013-12-01
Completion
2014-05-01
First posted
2014-06-11
Last updated
2014-06-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02160821. Inclusion in this directory is not an endorsement.