Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Completed · Phase 4
Conditions studied: Anterior Cruciate Ligament Rupture
In brief
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.
Key facts
- Study ID
- NCT02189317
- Run by
- Emory University
- People needed
- 50
- Starts
- 2014-08-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-07-27
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ages between 18 and 50 chronological years undergoing ACL reconstruction using a quadriceps tendon or BTB autograft.
You may not qualify if…
- Patients with known allergies to local anesthetics
- pregnant patients
- patients with a history of liver disease
- patients undergoing bilateral procedures
- Patients undergoing revision ACL surgery and patients undergoing ACL reconstruction using pediatric physeal sparing techniques
- Patients will also be excluded if any clinically significant event or condition is discovered during the time of, or after surgery that may render them medically unstable, or subject them to a surgical complication.
Where it is running
- Emory University Orthopaedic and Spine Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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