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

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Nemours Children's Health

Status and phase

Completed
Phase 4

Conditions

Anesthesia, Recovery Period

Treatments

Procedure: Transversus Abdominis Plane Block
Procedure: Caudal Epidural

Study type

Interventional

Funder types

Other

Identifiers

NCT02160821
1610841001

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

1 to 9 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

45 participants in 2 patient groups

Transversus Abdominis Plane Block
Experimental group
Description:
Transversus Abdominis Plane Block TAPB Ultrasound guided TAPB
Treatment:
Procedure: Transversus Abdominis Plane Block
Caudal Epidural Block
Experimental group
Description:
Caudal Epidural Block Caudal Block Neuraxial Block Ultrasound Guided Caudal Block
Treatment:
Procedure: Caudal Epidural

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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