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NCT05919732 · ClinicalTrials.gov registry record · Phase 4
Awake Caudal Catheter vs General Anesthesia
A Phase 4 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT05919732: Completed Phase 4 study, sponsored by Nemours Children's Clinic.
NCT05919732 is a Phase 4 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05919732, a Phase 4 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
It is well established that preterm inguinal hernias discovered in the NICU pose a significant surgical risk due to the associated co-morbid conditions that accompany these patients. Currently, the standard of care in the United States is general anesthesia. There have been studies that have established that elective outpatient repair of inguinal hernias found in the NICU can be safely performed. Patients that are ready for discharge from the NICU will have inguinal hernia repair prior to leaving. Inguinal hernia repair will also be done on those premature infants that are seen in the Nemours surgical clinic. Spinal anesthesia is currently the most common anesthetic procedure used in the surgical treatment of preterm inguinal hernias after general anesthesia. Caudal catheter technique has been proven to safely provide post-operative care of premature infants. The caudal catheter technique involves placement of a small catheter under ultrasound guidance into the caudal epidural canal to allow re-dosing of local anesthetic during the case and has been shown to be safe and effective management in neonates (Somri M, 2007).
Interventions
- DRUG Bupivacaine, Dexmedetomidine, Caffeine, Tylenol
- DRUG Propofol, rocuronium, caffeine, Tylenol, bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-03-08 |
| Est. Completion | 2018-03-08 |
| Phase | Phase 4 |
What the finished NCT05919732 record still lists
NCT05919732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Bupivacaine, Dexmedetomidine, Caffeine, Tylenol is the first listed.
NCT05919732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05919732 about?
NCT05919732 is a clinical study titled "Awake Caudal Catheter vs General Anesthesia". It is well established that preterm inguinal hernias discovered in the NICU pose a significant surgical risk due to the associated co-morbid conditions that accompany these patients. Currently, the standard of care in the United States is general anesthesia. There have been studies that have establi...
What is the current status of trial NCT05919732?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2016-03-08. Estimated completion is 2018-03-08.
What interventions are being tested in trial NCT05919732?
The interventions under investigation include: Bupivacaine, Dexmedetomidine, Caffeine, Tylenol (DRUG), Propofol, rocuronium, caffeine, Tylenol, bupivacaine (DRUG).
Who is sponsoring clinical trial NCT05919732?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05919732's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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