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

Sponsor
Nemours Children's Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02160821
Collaborator
(none)
45
1
2
40
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Caudal Epidural
  • Procedure: Transversus Abdominis Plane Block
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transversus Abdominis Plane Block

Transversus Abdominis Plane Block TAPB Ultrasound guided TAPB

Procedure: Transversus Abdominis Plane Block
Ultrasound Guided Transversus Abdominis Plane Block

Experimental: Caudal Epidural Block

Caudal Epidural Block Caudal Block Neuraxial Block Ultrasound Guided Caudal Block

Procedure: Caudal Epidural
Ultrasound Guided Caudal Block

Outcome Measures

Primary Outcome Measures

  1. Narcotic requirement [24 hours post intervention]

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

Secondary Outcome Measures

  1. episodes of nausea/vomiting [24 hours]

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

  2. anti-spasmodic requirement [24 hours post intervention]

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

  3. Pain Scores [24 hours post intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 9 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wolfson Children's Hospital, Baptist Medical Center- Downtown, 800 Prudential Drive Jacksonville Florida United States 32207

Sponsors and Collaborators

  • Nemours Children's Clinic

Investigators

  • Principal Investigator: Robert B Bryskin, MD, Nemours Children's Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT02160821
Other Study ID Numbers:
  • 1610841001
First Posted:
Jun 11, 2014
Last Update Posted:
Jun 11, 2014
Last Verified:
Jun 1, 2014

Study Results

No Results Posted as of Jun 11, 2014