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

June 9, 2014 updated by: Nemours Children's Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Wolfson Children's Hospital, Baptist Medical Center- Downtown, 800 Prudential Drive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic requirement
Time Frame: 24 hours post intervention
Narcotic requirement was recorded at 24 hours from the time of the block placement.
24 hours post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
episodes of nausea/vomiting
Time Frame: 24 hours
Episodes of nausea/vomiting were recorded at 24 hours from the time of the block placement.
24 hours
anti-spasmodic requirement
Time Frame: 24 hours post intervention
Anti-spasmodic requirement were recorded at 24 hours from the time of the block placement.
24 hours post intervention
Pain Scores
Time Frame: 24 hours post intervention
Pain scores (FLACC/FACES) were recorded at 24 hours from the time of the block placement
24 hours post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

June 9, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

June 11, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1610841001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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