Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
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|ClinicalTrials.gov Identifier: NCT02189317|
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : June 14, 2016
Last Update Posted : July 27, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Rupture||Drug: Exparel||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
This arm will receive 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|
- 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.
- 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.
- 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.
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
|United States, Georgia|
|Emory University Orthopaedic and Spine Center|
|Atlanta, Georgia, United States, 30324|
|Principal Investigator:||John Xerogeanes, MD||Emory University|