CompletedPhase 4

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

United States165 participantsStarted 2017-05-24

Plain-language 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.

Who can participate

Age range4 Months – 2 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of urethrocutaneous fistula

Timeframe: 1 year

Trial details

NCT IDNCT02861950

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-20

View on ClinicalTrials.gov More Hypospadias trials