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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 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 108 other Pain, Postoperative trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03001453
The ClinicalTrials.gov registry entry for NCT03001453 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (61% lower). The listed sponsor is American Hip Institute, which has 4 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.