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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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

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Anesthesia, Recovery Period

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Transversus Abdominis Plane Block

Transversus Abdominis Plane Block TAPB Ultrasound guided TAPB

Group Type EXPERIMENTAL

Transversus Abdominis Plane Block

Intervention Type PROCEDURE

Ultrasound Guided Transversus Abdominis Plane Block

Caudal Epidural Block

Caudal Epidural Block Caudal Block Neuraxial Block Ultrasound Guided Caudal Block

Group Type EXPERIMENTAL

Caudal Epidural

Intervention Type PROCEDURE

Ultrasound Guided Caudal Block

Interventions

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Caudal Epidural

Ultrasound Guided Caudal Block

Intervention Type PROCEDURE

Transversus Abdominis Plane Block

Ultrasound Guided Transversus Abdominis Plane Block

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No