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NCT03001453 · ClinicalTrials.gov registry record · Phase 2
Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management
A Phase 2 study of Pain, Postoperative, sponsored by American Hip Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 2
- Study locations
NCT03001453: Completed Phase 2 study of Pain, Postoperative, sponsored by American Hip Institute.
NCT03001453 is a Phase 2 study of Pain, Postoperative that has completed, run by American Hip Institute. The registered enrollment target is 107 participants, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03001453, a Phase 2 study of Pain, Postoperative, has completed, sponsored by American Hip Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine versus bupivacaine with epinephrine. This study is looking to see if one medication works better than the other in managing post-operative pain after THR. The study hypothesis is that Exparel® plus bupivacaine with epinephrine will demonstrate better pain management in THR patients post-operatively. Both medications are FDA-approved for post-operative analgesia.
Primary Outcome
All opioid doses were administered to the patient at 12-hour intervals post-surgery. Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended. The doses were then collected and converted to OMEs, in milligrams.
Conditions Studied
Interventions
- DRUG Liposomal Bupivacaine
- DRUG Saline
- DRUG 0.25% Bupivacaine with epinephrine
Study Locations (2)
Illinois
- Adventist Hinsdale Hospital - Hinsdale
- American Hip Institute - Westmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT03001453 record still lists
NCT03001453 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 272-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 3 interventions - of which Liposomal Bupivacaine is the first listed.
NCT03001453 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03001453 about?
NCT03001453 is a clinical study titled "Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management". The purpose of this study is to compare two medications currently injected intra-operatively to help decrease pain after surgery in patients undergoing a primary total hip replacement (THR). The two medications are Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephri...
What is the current status of trial NCT03001453?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2014-04. Estimated completion is 2016-03.
What conditions does trial NCT03001453 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT03001453?
The interventions under investigation include: Liposomal Bupivacaine (DRUG), Saline (DRUG), 0.25% Bupivacaine with epinephrine (DRUG).
Who is sponsoring clinical trial NCT03001453?
This trial is sponsored by American Hip Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03001453 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain, Postoperative
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 NCT03001453's enrollment target sits among peer trials
107 42nd of 113 higher than 72 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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