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Clinical Trials/NCT02160821
NCT02160821
Completed
Phase 4

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

Nemours Children's Clinic1 site in 1 country45 target enrollmentJanuary 2011

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Anesthesia, Recovery Period
Sponsor
Nemours Children's Clinic
Enrollment
45
Locations
1
Primary Endpoint
Narcotic requirement
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
May 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery

Exclusion Criteria

  • Coagulation status or anatomic variations precluded safe placement of either TAPB or caudal epidural,
  • there was a preexisting chronic pain disorder,
  • there was a history of constipation that persisted despite appropriate treatment and that may have impacted postoperative pain assessments,
  • 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.

Outcomes

Primary Outcomes

Narcotic requirement

Time Frame: 24 hours post intervention

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

Secondary Outcomes

  • episodes of nausea/vomiting(24 hours)
  • Pain Scores(24 hours post intervention)
  • anti-spasmodic requirement(24 hours post intervention)

Study Sites (1)

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