Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
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| ClinicalTrials.gov Identifier: NCT02189317 |
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Recruitment Status :
Completed
First Posted : July 14, 2014
Results First Posted : June 14, 2016
Last Update Posted : July 27, 2016
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Sponsor:
Emory University
Information provided by (Responsible Party):
John Xerogeanes, Emory University
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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 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
| Arm | Intervention/treatment |
|---|---|
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Experimental: Exparel
This arm will receive Exparel
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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 |
Primary Outcome Measures :
- 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 :
- 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.
Information from the National Library of Medicine
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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.
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
| United States, Georgia | |
| Emory University Orthopaedic and Spine Center | |
| Atlanta, Georgia, United States, 30324 | |
Sponsors and Collaborators
Emory University
Investigators
| Principal Investigator: | John Xerogeanes, MD | Emory University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |