Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

NCT ID: NCT02189317

Last Updated: 2016-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Exparel

This arm will receive Exparel

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Liposomal Bupivacaine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

John Xerogeanes

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Xerogeanes, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Orthopaedic and Spine Center

Atlanta, Georgia, United States

Countries

United States

References

Premkumar A, Samady H, Slone H, Hash R, Karas S, Xerogeanes J. Liposomal Bupivacaine for Pain Control After Anterior Cruciate Ligament Reconstruction: A Prospective, Double-Blinded, Randomized, Positive-Controlled Trial. Am J Sports Med. 2016 Jul;44(7):1680-6. doi: 10.1177/0363546516640772. Epub 2016 Apr 25.

Reference Type: DERIVED

PMID: 27159290 (View on PubMed)

Other Identifiers

IRB00073168

Identifier Type: -

Identifier Source: org_study_id