Osteoarthritis, Knee Clinical Trial
Official title:
A Prospective Randomized Case Series Comparison on the Clinical Efficacy of Exparel Local Anesthetic in Total Knee Arthroplasty Patients
This is a prospective, single-center, single-blinded, randomized, case-control study. The study is conducted by a single investigator at an orthopedic surgery institute, with a minimum 6 week post operative follow-up period of TKA patients who receive Exparel compared with the surgeon's standard method (detailed below) for pain management intraoperatively.
This is a prospective, single-center, single-blinded, randomized, case-control study. The
study is conducted by a single investigator at an orthopedic surgery institute, with a
minimum 6 week post operative follow-up period. Subjects scheduled for a planned total knee
arthroplasty procedure will be consented and those meeting study criteria will be randomized
to receive intra-operative injections at the surgical site of liposomal bupivicaine plus a
multi-drug cocktail, or a multi-drug cocktail alone.
This study will recruit subjects on an ongoing basis with a minimum of 130 study participants
and a maximum of 156. Efficacy data on surgical pain control and safety data will be
collected at frequent intervals during the hospitalization. Each study participant will be
followed for a minimum 6 week follow-up period.
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