Phase 4
Completed N=32
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Rupture
Source: ClinicalTrials.gov NCT02189317 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: Change in Numerical Rating Scale (NRS) Pain Score — 3.6; 4.7; 5.0; 4.1 units on a scale
◆ Published Evidence
Established
38citations · ~4 / year
Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial.
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.
Linked Publications
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Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Numerical Rating Scale (NRS) Pain Score |
3.6; 4.7; 5.0; 4.1; 5.7; 4.5 | — |
| SECONDARY Change in Home Opioid Use |
10.2; 9.3; 1.6; 2.5; 4.9; 4.1 | — |
| SECONDARY Difference in Time to First Opioid Use |
3.2; 3.1 | — |
Eligibility Criteria
Inclusion Criteria
- Ages between 18 and 50 chronological years undergoing ACL reconstruction using a quadriceps tendon or BTB autograft.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02189317) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.