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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: Completed Phase 4 study of Pain, Postoperative and Bariatric Surgery Candidate, sponsored by University of California, San Francisco.
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 113 other Pain, Postoperative trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
in hospital total oral and IV morphine equivalents required after laparoscopic 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 |
What the finished NCT03196505 record still lists
NCT03196505 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 271-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (15% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03196505's enrollment target sits among peer trials
231 14th of 113 higher than 100 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative 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.
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