NCT02861950

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Male
• Age: 4 Months – 2 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis: There is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block. The investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. Meatal anatomy will be graded by the urologist in the anesthetized child according to the HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the total score and the individual component scores will be recorded. The operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.

Conditions

• Hypospadias
• Urethrocutaneous Fistula

Interventions

Type	Name	Description
DRUG	Caudal block with ropivacaine	Patients in this arm will receive a caudal block with ropivacaine
DRUG	penile nerve block with bupivacaine	Patients in this arm will receive a penile block with bupivacaine

Timeline

• Start date: 2017-05-24
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2016-08-10
• Last updated: 2024-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study