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Completed

NCT Number: NCT02189317

Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory University Orthopaedic and Spine Center

Atlanta, Georgia, 30324, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Liposomal Bupivacaine

Primary outcomes

  1. Change in Numerical Rating Scale (NRS) Pain Score

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

    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.

Secondary outcomes

  1. Change in Home Opioid Use

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

    The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.

  2. Difference in Time to First Opioid Use

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

    The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 14, 2014
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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