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.

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.

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