Liposomal Bupivacaine Use in Third Molar Impaction Surgery: INNOVATE Study.

ABSTRACT: The analgesic efficacy and safety of liposomal bupivacaine (LB) in third molar extraction was evaluated in this phase 3, double-blind, placebo-controlled study of subjects undergoing bilateral third molar extraction. Subjects were randomized 2 : 1 to infiltration with LB (133 mg/10 mL) or placebo, and received opioid rescue medication as needed. Primary efficacy measure was cumulative area under the curve (AUC) of numeric rating scale (NRS) pain severity scores through 48 hours (AUC of NRS_0-48) postsurgery. Other measures included AUC of NRS_0-24, AUC of NRS_0-72, and AUC of NRS_0-96, and incidence of adverse events. There were 150 subjects in the primary efficacy population (n = 99 LB, n = 51 placebo) and 89 in the per-protocol population (n = 59 L

SUBMITTER: Lieblich SE 

PROVIDER: S-EPMC5579813 | biostudies-literature | Fall 2017

REPOSITORIES: biostudies-literature