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NCT03769714 · ClinicalTrials.gov registry record · Phase 4
EXPAREL for Minimally Invasive Supracervical Hysterectomies
A Phase 4 study, sponsored by Maimonides Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT03769714: Completed Phase 4 study, sponsored by Maimonides Medical Center.
NCT03769714 is a Phase 4 study that has completed, run by Maimonides Medical Center. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03769714, a Phase 4 study, has completed, sponsored by Maimonides Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The aim of the of the study is a reduction in minimally invasive supracervical hysterectomy postsurgical pain, which may result in less need for supplemental opioid pain medications, fewer opioid related adverse events, and a better recovery experience for patients, which may offer an economic benefit to health care systems. Intracervical preoperative dose of Exparel during minimally invasive (robotic--assisted or traditional laparoscopy) supracervical hysterectomy reduces cumulative pain scores for up to 24 hours and reduces overall requests for break through (additional) analgesia with opioid consumption compared with placebo.
Primary Outcome
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).at 12 hours postoperatively
Interventions
- DRUG Exparel
- DRUG Saline Solution for Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2019-06-30 |
| Phase | Phase 4 |
What the finished NCT03769714 record still lists
NCT03769714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Exparel is the first listed.
NCT03769714 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03769714 about?
NCT03769714 is a clinical study titled "EXPAREL for Minimally Invasive Supracervical Hysterectomies". The aim of the of the study is a reduction in minimally invasive supracervical hysterectomy postsurgical pain, which may result in less need for supplemental opioid pain medications, fewer opioid related adverse events, and a better recovery experience for patients, which may offer an economic benef...
What is the current status of trial NCT03769714?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2018-10-01. Estimated completion is 2019-06-30.
What interventions are being tested in trial NCT03769714?
The interventions under investigation include: Exparel (DRUG), Saline Solution for Injection (DRUG).
Who is sponsoring clinical trial NCT03769714?
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 NCT03769714's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 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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