NCT02189317

Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anterior Cruciate Ligament Rupture

Interventions

Type	Name	Description
DRUG	Exparel	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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-07-14
• Last updated: 2016-07-27
• Results posted: 2016-06-14

Locations

1 site across 1 country: United States