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NCT02861950 · ClinicalTrials.gov registry record · Phase 4
Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 165
- Enrollment target
NCT02861950: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT02861950 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 165 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02861950, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 165 participants
- Enrollment target
Study 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.
Primary Outcome
Presence of a urethrocutaneous fistula at postoperative visit up to 1 year after surgery.
Interventions
- DRUG Caudal block with ropivacaine
- DRUG penile nerve block with bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2023-09-20 |
| Phase | Phase 4 |
What the finished NCT02861950 record still lists
NCT02861950 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Caudal block with ropivacaine is the first listed.
NCT02861950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02861950 about?
NCT02861950 is a clinical study titled "Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants?". 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 blo...
What is the current status of trial NCT02861950?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 165 participants. The study started on 2017-05-24. Estimated completion is 2023-09-20.
What interventions are being tested in trial NCT02861950?
The interventions under investigation include: Caudal block with ropivacaine (DRUG), penile nerve block with bupivacaine (DRUG).
Who is sponsoring clinical trial NCT02861950?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02861950's enrollment target sits among peer trials
165 492nd of 2000 higher than 1,505 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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