October 30th, 2018 , The Journal of Arthroplasty

Corrigendum to “Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial” (UPDATE)

Authors: Mont MA, Beaver WB, Dysart SH, Barrington JW, Del Gaizo DJ

Summary Update:

The authors would like to inform the readership that during recent discussions with the US Food and Drug Administration (FDA) related to the registration trials for the label expansion of liposomal bupivacaine (LB; EXPAREL®, bupivacaine liposome injectable suspension; Pacira Pharmaceuticals, Inc., Parsippany, NJ), opioid conversion factors used in the statistical analyses were updated to reflect current knowledge of their relative potencies used in medical practice. The updates were approved by the FDA, as there is no current standard for opioid conversions. To maintain consistency with the FDA registration trials and the trials that will be registered with the European Medicines Agency (EMA; the European equivalent of the FDA), the conversion factors used in the PILLAR study were also updated. In place of intravenous morphine equivalent dose (MED), opioid consumption has been converted to oral MED using an updated set of conversion factors. These updates do not alter the original study conclusions. The changes affected both study arms equally and did not alter the findings or conclusions.

CLICK HERE to read the full text.

Back