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Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189317
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : June 14, 2016
Last Update Posted : July 27, 2016
Sponsor:
Information provided by (Responsible Party):
John Xerogeanes, Emory University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Drug: Exparel Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Study Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exparel
This arm will receive Exparel
 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.
Other Name: Liposomal Bupivacaine
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189317


Locations
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United States, Georgia
Emory University Orthopaedic and Spine Center
Atlanta, Georgia, United States, 30324
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: John Xerogeanes, MD Emory University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: John Xerogeanes, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02189317    
Other Study ID Numbers: IRB00073168
First Posted: July 14, 2014    Key Record Dates
Results First Posted: June 14, 2016
Last Update Posted: July 27, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents