Table 2

Efficacy results for the primary and key secondary endpoints (ITT population)*

EndpointSaline placebo
Bupivacaine HCl
50 mg
60 mg/1.8 mg
AUC0-72 of the NRS pain intensity scores†
 Mean (SD)445.3 (155.8)393.5 (153.8)323.3 (182.6)
 Primary endpoint: p value‡ versus saline placebo<0.0001
 Secondary endpoint: p value‡ versus bupivacaine HCl0.0002
Opioid consumption through 72 hours (MME)
 Mean (SD)30.06 (21.01)25.09 (21.55)18.80 (19.80)
 Median (min, max)25.0 (0, 80.0)17.5 (0, 92.5)12.5 (0, 83.0)
 Secondary endpoint: p value§ versus saline placebo<0.0001
 Secondary endpoint: p value§ versus bupivacaine HCl0.0022
Opioid free through 72 hours
 n (%)2 (2.0)17 (11.0)45 (28.7)
 P value§ versus saline placebo<0.0001
 Secondary end point: p value¶ versus bupivacaine HCl0.0001
  • Opioid free through 72 hours is defined as subjects who had total MME opioid dose=0 from 0–72 hours. All doses of opioid rescue medication are expressed as intravenous MME.

  • *ITT population includes all subjects who are randomized and receive study drug. This population was used as the primary analysis population for all efficacy endpoints.

  • †Analyzed using wWOCF.

  • ‡P values reflect results of an analysis of variance with randomized treatment as the main effect.

  • §P values were obtained using the Wilcoxon rank-sum test.

  • ¶P values from Fisher's exact test.

  • AUC0-72, area under the curve through 72 hours; HCl, hydrochloride; ITT, intent to treat; MME, morphine milligram equivalent; NRS, Numeric Rating Scale of the pain intensity score; wWOCF, windowed worst observation carried forward.