Fig. 2.
Results of primary analysis. We first assessed noninferiority of the lidocaine group on each outcome, using a one-sided significance criterion of 0.025; such noninferiority is represented by differences in means—lidocaine minus placebo—that are either negative, or not meaningfully positive. Because significant noninferiority was found on both outcomes (P < 0.001 and P = 0.010 for verbal response scale (VRS) pain score and mg intravenous (IV) morphine equivalent dose, respectively, and graphically indicated by the 95% CIs being entirely within the displayed noninferiority region for each outcome), we proceeded to assess superiority on at least one of the outcomes, using a Bonferroni-adjusted one-sided significance criterion of 0.0125. Superiority on pain was found (P < 0.001; 95% CI entirely below a difference of 0 VRS units), whereas, superiority on total 48-h postoperative IV morphine equivalent dose was not found (P = 0.10; 95% CI overlaps 0%). Estimates and 95% CIs (confidence level adjusted based on the relevant significance criterion for each outcome) are given in the figure; these estimates were adjusted for American Society of Anesthesiologists Physical Status, number of levels operated, and use of instrumentation.