Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

Emory University

Status and phase

Completed

Phase 4

Conditions

Anterior Cruciate Ligament Rupture

Treatments

Drug: Exparel

Study type

Interventional

Funder types

Other

Identifiers

NCT02189317

IRB00073168

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.