Completed

NCT Number: NCT02160821

TAPB vs. Caudal 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.

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Key information

Conditions

Anesthesia, Recovery Period

Age range

1 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wolfson Children's Hospital, Baptist Medical Center- Downtown, 800 Prudential Drive

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Caudal Epidural

Procedure

Ultrasound Guided Caudal Block

transversus abdominis plane block

Procedure

Ultrasound Guided Transversus Abdominis Plane Block

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

Time frame: 24 hours

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

Time frame: 24 hours post intervention

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

Time frame: 24 hours post intervention

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

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: Jun 11, 2014
Registry last updated: Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.