Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Primary Purpose
Anterior Cruciate Ligament Rupture
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Rupture
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.
Sites / Locations
- Emory University Orthopaedic and Spine Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exparel
Control
Arm Description
This arm will receive Exparel
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Home Opioid Use
The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.
Difference in Time to First Opioid Use
The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02189317
Brief Title
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Official Title
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel
Arm Type
Experimental
Arm Description
This arm will receive Exparel
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Exparel
Other Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Numerical Rating Scale (NRS) Pain Score
Description
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.
Time Frame
Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
Secondary Outcome Measure Information:
Title
Change in Home Opioid Use
Description
The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.
Time Frame
Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
Title
Difference in Time to First Opioid Use
Description
The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.
Time Frame
Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Xerogeanes, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Orthopaedic and Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27159290
Citation
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.
Results Reference
derived
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Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
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