Overview

Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?

Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
Male
Summary
This is a prospective randomized multi-center non-inferiority trial conducted through the Pediatric Regional Anesthesia Network study sites to determine if caudal block increases the incidence of urethrocutaneous fistula following distal or mid shaft hypospadias repair compared with penile nerve block.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Colorado, Denver
Collaborators:
Boston Children's Hospital
Boston Children’s Hospital
Children's Healthcare of Atlanta
Children's Medical Center Dallas
Children's National Health System
Dartmouth-Hitchcock Medical Center
James Whitcomb Riley Hospital for Children
Joe DiMaggio Children's Hospital
Northwestern University
Oregon Health and Science University
Seattle Children's Hospital
Stanford University
Texas Children's Hospital
The University of Texas Health Science Center, Houston
University of Iowa
University of Michigan
University of Mississippi Medical Center
University of New Mexico
University of Wisconsin, Madison
Treatments:
Bupivacaine
Ropivacaine
Criteria
Inclusion Criteria:

- infants/ children with midshaft or distal hypospadias undergoing primary single stage
repair in one of the Pediatric Regional Anesthesia Network participating centers.

Exclusion Criteria:

- prior hypospadias surgery,

- proximal or penoscrotal hypospadias,

- abnormal caudal anatomy or spinal dysraphism,

- cyanotic congenital heart disease,

- infection or rash at the block injection site.