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.