Clinical trial NCT02160821: TAPB vs. Caudal for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
Official title: Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia, Recovery Period
Keywords: Transversus Abdominis Plane Block
Caudal Epidural
Pediatric Pain control
Pain control for Lower Abdominal Surgery
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Narcotic requirement
timeFrame: 24 hours post intervention
Secondary outcomes:
measure: episodes of nausea/vomiting
timeFrame: 24 hours
measure: anti-spasmodic requirement
timeFrame: 24 hours post intervention
measure: Pain Scores
timeFrame: 24 hours post intervention
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Wolfson Children's Hospital, Baptist Medical Center- Downtown, 800 Prudential Drive
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Robert B Bryskin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.
citation: Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.
citation: Bryskin RB, Londergan B, Wheatley R, Heng R, Lewis M, Barraza M, Mercer E, Ye G. Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial. Anesth Analg. 2015 Aug;121(2):471-8. doi: 10.1213/ANE.0000000000000779.