NCT02160821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

2.9 years

First QC Date

May 29, 2014

Last Update Submit

June 9, 2014

Conditions

Anesthesia, Recovery Period

Keywords

Transversus Abdominis Plane BlockCaudal EpiduralPediatric Pain controlPain control for Lower Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

  • Narcotic requirement

    Narcotic requirement was recorded at 24 hours from the time of the block placement.

    24 hours post intervention

Secondary Outcomes (3)

  • episodes of nausea/vomiting

    24 hours

  • anti-spasmodic requirement

    24 hours post intervention

  • Pain Scores

    24 hours post intervention

Study Arms (2)

Transversus Abdominis Plane Block

EXPERIMENTAL

Transversus Abdominis Plane Block TAPB Ultrasound guided TAPB

Procedure: Transversus Abdominis Plane Block

Caudal Epidural Block

EXPERIMENTAL

Caudal Epidural Block Caudal Block Neuraxial Block Ultrasound Guided Caudal Block

Procedure: Caudal Epidural

Interventions

Caudal EpiduralPROCEDURE

Ultrasound Guided Caudal Block

Caudal Epidural Block
Transversus Abdominis Plane BlockPROCEDURE

Ultrasound Guided Transversus Abdominis Plane Block

Transversus Abdominis Plane Block

Eligibility Criteria

Age1 Year - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jacksonville, Florida, 32207, United States

Location

Related Publications (3)

  • 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.

    PMID: 16094063BACKGROUND

  • 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.

    PMID: 17513626BACKGROUND

  • 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.

    PMID: 25902326DERIVED

MeSH Terms

Interventions

Anesthesia, Caudal

Intervention Hierarchy (Ancestors)

Anesthesia, EpiduralAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Robert B Bryskin, MD

    Nemours Children's Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 11, 2014

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

May 1, 2014

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations

US(1)