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NCT03196505 · ClinicalTrials.gov registry record · Phase 4
The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery
A Phase 4 study of Pain, Postoperative and Bariatric Surgery Candidate, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 231
- Enrollment target
- 1
- Study location
NCT03196505 is a Phase 4 study of Pain, Postoperative and Bariatric Surgery Candidate that has completed, run by University of California, San Francisco. The registered enrollment target is 231 participants, below the 271-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03196505, a Phase 4 study of Pain, Postoperative and Bariatric Surgery Candidate, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 231 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour bupivacaine that is slowly released from tissue over the course of three days. Having a long acting local anesthetic should provide better pain control than conventional bupivacaine which has a 3.5-hour half-life. In some studies, the use of liposomal bupivacaine has been shown to decrease pain and narcotic use after surgery. This has not yet been studied in bariatric patients and the use of liposomal bupivacaine can potentially improve patient post-operative pain control, decrease narcotic use, decrease hospital length of stay and readmission rates and improve patient satisfaction after bariatric surgery.
Conditions Studied
Interventions
- DRUG Bupivacaine
- DRUG Exparel 266 MG Per 20 ML Injection
Study Locations (1)
California
- Fresno Heart and Surgical Hospital - Fresno
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03196505
The ClinicalTrials.gov registry entry for NCT03196505 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 271-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (15% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Bupivacaine is the first listed.
NCT03196505 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03196505 about?
NCT03196505 is a clinical study titled "The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery". This study is prospective, randomized trial in which the efficacy of liposomal bupivacaine (Exparel®) is compared to standard bupivacaine local surgical site injection in reducing total IV and oral morphine equivalents required after laparoscopic bariatric surgery. Liposomal bupivacaine is a 72-hour...
What is the current status of trial NCT03196505?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 231 participants. The study started on 2017-12-04. Estimated completion is 2019-07-31.
What conditions does trial NCT03196505 study?
This clinical trial studies the following conditions: Pain, Postoperative, Bariatric Surgery Candidate.
What interventions are being tested in trial NCT03196505?
The interventions under investigation include: Bupivacaine (DRUG), Exparel 266 MG Per 20 ML Injection (DRUG).
Who is sponsoring clinical trial NCT03196505?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03196505 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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