drugset / Trial / NCT02861950
Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?
Phase 4
Completed
165 enrolled
University of Colorado, Denver
Boston Children's Hospital · collabChildren's Medical Center of Dallas/UT Southwestern · collabChildren's National Research Institute · collabDartmouth-Hitchcock Medical Center · collabStanford University · collabUniversity of Michigan · collabUniversity of Mississippi Medical Center · collabUniversity of New Mexico · collabUniversity of Wisconsin, Madison · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-05-24
- Primary completion
- 2023-09-20
- Completion
- 2023-09-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.25 % | Other |
| Comparator | Ropivacaine | Other / unclassified | 0.2 % | Other |