Status:
COMPLETED
Liposomal Bupivacaine Versus Standard of Care in Total Knee Surgery
Lead Sponsor:
OhioHealth
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total knee arthroplasty, as compared to standard of care analgesia.
Detailed Description
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its u...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Scheduled to undergo total knee arthroplasty (TKA) performed by the principal investigator
Exclusion
- Age \<18 years
- Pregnant or breastfeeding
- Non-English-speaking
- Unable to give informed consent
- Patients admitted from or discharged to a medical facility (due to likelihood of limited mobility and/or required minimum lengths of stay, confounding primary outcome), including other hospitals, skilled nursing facilities, long-term acute care hospitals, etc.
- Patients unable to complete a device-assisted 140 foot walk at baseline
- Patients with contraindication(s) to any bupivacaine or ropivacaine formulation, to nerve blocks or any of the local agents used (IV morphine, ketorolac, or methylprednisolone).
- Patients on a long-acting maintenance opioid prior to admission for surgery (e.g., methadone, oxycontin)
- Patients undergoing simultaneous bilateral TKAs, as this would increase the dose of Exparel per patient (we are limited to one dose per patient)
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02219087
Start Date
August 1 2014
End Date
March 1 2016
Last Update
January 2 2018
Active Locations (1)
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1
OhioHealth Grant Medical Center Bone and Joint Center
Columbus, Ohio, United States, 43215