ArticleInternational journal of surgery (London, England)2026
Efficacy and safety of HSK16149 for postoperative pain in Chinese patients after orthopedic surgery: a phase 2 randomized clinical trial.
Article in International journal of surgery (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Importance: Some Chinese patients undergoing orthopedic surgery may require more effective and safer analgesics to adequately relieve moderate to severe postoperative pain. Objective: To evaluate the efficacy and safety of crisugabalin (HSK16149), a calcium channel α2δ subunit ligand oral capsule, in managing postoperative pain in Chinese patients undergoing orthopedic surgery. Methods: This Phase 2 trial was conducted from 8 March to 5 July 2023, across 20 clinical hospitals in China and employed a double-blind, randomized design, which enrolled Chinese patients scheduled for elective orthopedic surgery under general anesthesia. Patients were randomized 1:1:1:1:1 to receive HSK16149, 40 mg twice before surgery (80 mg used in total), 60 mg twice (120 mg used in total), 40 mg four times before and after surgery (160 mg used in total), 60 mg four times (240 mg used in total), and receive placebo four times before and after surgery. The primary outcome was the total morphine dose within the 24-hour postoperative period, including usage from the patient-controlled analgesia device and any additional remedial analgesia. Results: A total of 24 patients were excluded from the analysis, resulting in 235 participants randomized into the following groups: 80 mg ( Conclusions: HSK16149 capsules reduced postoperative opioid consumption in Chinese patients undergoing orthopedic surgery, showing that receiving 240 mg HSK16149 was recommended and appeared to be well tolerated.
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