Tegileridine for moderate-to-severe acute pain following abdominal surgery: A randomized, double-blind, phase 3 clinical trial.

Abstract

Tegileridine is a biased μ-opioid receptor agonist that selectively activates the G protein pathway, designed to provide analgesia with fewer opioid-related adverse effects. In this phase 3 study, 526 patients with postoperative pain after abdominal surgery were randomized and received placebo, tegileridine at 0.75 mg, tegileridine at 1.0 mg, or morphine. For the primary outcome of effective analgesia, the mean (SD) summed pain intensity difference at rest over the first 24 h from time 0 (SPID₂₄) scores are -61.15 (28.25) and -68.98 (30.33) for the 0.5 and 0.75 mg doses of tegileridine, respectively, compared with -49.63 (29.35) in the placebo group (all p < 0.001) and -71.16 (34.76) in the morphine group. The total pain relief scores (mean [SD]) at 24 h were 58.76 (21.79) with 0.75 mg tegileridine and 61.95 (18.94) with 1.0 mg tegileridine, compared with 47.56 (21.00) with placebo and 59.09 (19.34) with morphine. In summary, tegileridine provides effective analgesia that was significantly superior to placebo and comparable to morphine.