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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Caudal Epidural | Ultrasound Guided Caudal Block |
| PROCEDURE | Transversus Abdominis Plane Block | Ultrasound 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.