Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

NCT02189317 | Completed Phase 4 Results

• 1 other identifier: IRB00073168
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Home Opioid Use

  Day of Surgery, Post-Operative Day 6 (Up to 144 hours)

• Difference in Time to First Opioid Use

  Day of Surgery, Post-Operative Day 6 (Up to 144 hours)

Study Arms (2)

Exparel

EXPERIMENTAL

This arm will receive Exparel

Drug: Exparel

Control

NO INTERVENTION

Interventions

Exparel 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.

Also known as: Liposomal Bupivacaine

Exparel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages between 18 and 50 chronological years undergoing ACL reconstruction using a quadriceps tendon or BTB autograft.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Orthopaedic and Spine Center

Atlanta, Georgia, 30324, United States

Location

Related Publications (1)

• 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.

  PMID: 27159290 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Limitations and Caveats

The study lacked a third comparison group of participants who received placebo which may have provided another internal control. Additionally, there was a difference in the total milligrams of bupivacaine administered in each study group.

Results Point of Contact

• Title: John W Xerogeanes, MD
• Organization: Emory University

jxeroge@emory.edu

404-778-7202

Study Officials

• John Xerogeanes, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 27, 2016
• Results First Posted: June 14, 2016

Record last verified: 2016-06

Locations

US (1)