• Joseph Dasta, Sonia Ramamoorthy, Gary Patou, and Raymond Sinatra.
• The University of Texas College of Pharmacy, Austin, TX, USA. jdasta@mail.utexas.edu
• Curr Med Res Opin. 2012 Oct 1; 28 (10): 1609-15.

ObjectiveAssess comparative efficacy of liposome bupivacaine administered at doses ≤266 mg and bupivacaine HCl administered at doses ≤200 mg for postsurgical analgesia.Research Design And MethodsAnalysis of pooled efficacy and safety data from nine double-blind, placebo or active (bupivacaine HCl) controlled multimodal analgesia studies using a single dose of liposome bupivacaine or comparator, given via administration into the surgical site before end of surgery (i.e., inguinal hernia repair, total knee arthroplasty, hemorrhoidectomy, breast augmentation, or bunionectomy). Data from study arms that received liposome bupivacaine doses ≤266 mg were included.Clinical Trial RegistrationPooled data analysis includes nine studies: Study 1 - NCT01203644; Study 2 - NCT00485433; Study 3 - NCT00485693; Study 4 - NCT00529126; Study 5 - NCT00745290; Study 6 - NCT00744848; Study 7 - NCT00813111; Study 8 - NCT00890721; Study 9 - NCT00890682.Main Outcome MeasuresOutcome measures included area under the curve (AUC) of pain intensity scores assessed by numeric rating scale (NRS) through 72 h postsurgery, time to first use of rescue opioid medications, total amount (mg) of opioid medications used, and occurrence of opioid-related adverse events (ORAEs). Incidence of overall AEs was also assessed.ResultsMean cumulative pain score (AUC of NRS through 72 h) was significantly lower with liposome bupivacaine (283) compared with bupivacaine HCl (329, p = 0.039). Median time from administration of study drug to first use of opioid rescue medication was significantly longer for liposome bupivacaine (10 h vs 3 h, p < 0.0001). Liposome bupivacaine was associated with a significant reduction in opioid use (12 mg vs 19 mg; p < 0.0001) and incidence of ORAEs (20% vs 36%; p < 0.0001), compared with bupivacaine HCl.ConclusionsIn this pooled analysis from nine studies representing five different surgical procedures, liposome bupivacaine administered at doses ≤266 mg in a multimodal setting was associated with statistically significant and clinically meaningful lower cumulative pain score at 72 h, delayed and less consumption of opioids, and fewer ORAEs than bupivacaine HCl.

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