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NCT02189317 · ClinicalTrials.gov registry record · Phase 4
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
A Phase 4 study of Anterior Cruciate Ligament Rupture, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT02189317: Completed Phase 4 study of Anterior Cruciate Ligament Rupture, sponsored by Emory University.
NCT02189317 is a Phase 4 study of Anterior Cruciate Ligament Rupture that has completed, run by Emory University. The registered enrollment target is 50 participants, below the 142-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02189317, a Phase 4 study of Anterior Cruciate Ligament Rupture, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into treatment and control arms. The treatment arm will include 40 patients receiving liposomal bupivacaine intra-operatively in addition to the current standard pain control regimen. The control group will include 40 patients receiving the standard post-operative pain control regimen. Patients will be assessed to identify differences in post-operative pain, satisfaction, as well as concomitant pain medication use. Post-operative range of motion will also be assessed.
Primary Outcome
The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to "no pain" and ten is equal to "worst possible" pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.
Conditions Studied
Interventions
- DRUG Exparel
Study Locations (1)
Georgia
- Emory University Orthopaedic and Spine Center - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-08 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
What the finished NCT02189317 record still lists
NCT02189317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 142-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Anterior Cruciate Ligament Rupture appearing as the primary indexed condition, and to 1 intervention - of which Exparel is the first listed.
NCT02189317 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT02189317 about?
NCT02189317 is a clinical study titled "Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction". This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into...
What is the current status of trial NCT02189317?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2014-08. Estimated completion is 2015-03.
What conditions does trial NCT02189317 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Rupture.
What interventions are being tested in trial NCT02189317?
The interventions under investigation include: Exparel (DRUG).
Who is sponsoring clinical trial NCT02189317?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02189317 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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participants (enrollment target), bucketed by value
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