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NCT03638011 · ClinicalTrials.gov registry record · Phase 4
A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine
A Phase 4 study, sponsored by Maimonides Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT03638011: Clinical Trial Phase 4 study, sponsored by Maimonides Medical Center.
NCT03638011 is a Phase 4 study that was terminated before completion, run by Maimonides Medical Center. The registered enrollment target is 71 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03638011, a Phase 4 study, was terminated before completion, sponsored by Maimonides Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
The primary objective is to reduce or eliminate the use of all narcotics/opiates for post Cesarean section pain management. The investigators hypothesize that in comparison with epidural or intrathecal Duramorph, a TAP block with liposomal bupivacaine (Exparel) will provide better, longer-acting pain control and will significantly reduce the use of post-operative IV or p.o. opiates. This is a prospective, randomized clinical trial.
Primary Outcome
To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).
Interventions
- DRUG Exparel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 4 |
Why NCT03638011 stopped before completion
NCT03638011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Exparel is the first listed.
NCT03638011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03638011 about?
NCT03638011 is a clinical study titled "A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine". The primary objective is to reduce or eliminate the use of all narcotics/opiates for post Cesarean section pain management. The investigators hypothesize that in comparison with epidural or intrathecal Duramorph, a TAP block with liposomal bupivacaine (Exparel) will provide better, longer-acting pai...
What is the current status of trial NCT03638011?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2018-09-25. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT03638011?
The interventions under investigation include: Exparel (DRUG).
Who is sponsoring clinical trial NCT03638011?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03638011's enrollment target sits among peer trials
71 1040th of 2000 higher than 958 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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