Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? A Multi-center Prospective Randomized Trial.

15-2343

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.

2017-05-24

2023-09-20

2023-09-20

Completed

Early phase I

165

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 165, 'type': 'ACTUAL'}}

2024-07-01