Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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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.

Official Title
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Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Drug: Exparel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel<br>This arm will receive Exparel | Drug: Exparel<br>* For the treatment group a total of 40 cc consisting of 20 cc of 1.3% Exparel® and 20 cc of 0.5 % marcaine will be administered to the ACL harvest site, into the periosteum surrounding the distal tibial tunnel site, and in the proximity of the skin incisions. No infiltration of Exparel will be provided intra-articularly.<br>* Other names: Liposomal Bupivacaine;|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numerical Rating Scale (NRS) Pain Score | 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. | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Home Opioid Use | The difference in amount of Percocet (7.5/325 tablets) usage post-surgery. | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) | 
| Difference in Time to First Opioid Use | The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery. | Day of Surgery, Post-Operative Day 6 (Up to 144 hours) |