Northern Westchester Hospital at Mt. Kisco, New York, has extended the enrollment period for a clinical trial to evaluate a pain management procedure for a total knee replacement. Known as “The Pacira Trial”, the study will evaluate the safety, efficacy and pharmacokinetics of a single injection femoral nerve block with liposome bupivacaine for post-operative pain for patients undergoing a total knee replacement.
Seeking Knee Pain Clinical Trial Subjects
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Knee replacement surgery is one of the most common joint replacement procedures and is performed on over 600, 000 people worldwide each year. The Pacira Trial is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, dose-ranging study. Enrollment for the Pacira Trial will end October 2013.
To be eligible for the trial a patient must be over the age of 18, weigh more than 110 pounds, and must not have previously participated in liposome bupivacain studies. Stuart Styles, M.D., co-director of Joint Replacement Surgery, Orthopedic and Spine Institute is the principal investigator for the Pacira Trial along with co-investigator Christie Sasso, M.D. For information about joining the study, call 914-666-1366 or the hospital.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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