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Abstract
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Background and Aims The management of perioperative analgesia in clinical practice is often distressing and full of challenges. Opioids are recommended as perioperative analgesic treatment for patients undergoing orthopedic surgery, but there are not widely use resulted from adverse effects. This study aimed to assess the efficacy and safety of Crisugabalin for perioperative analgesia in patients undergoing orthopedic surgery.
Methods Subjects (18-75 years) scheduled for elective orthopedic surgery under general anesthesia, which was expected to take no more than 4 h, postoperative analgesia expected to last >24 h were randomized to preoperative 40mg Crisugabalin and postoperative placebo (40mgPre), preoperative 60mg Crisugabalin and postoperative placebo (60mgPre), preoperative and postoperative 40mg Crisugabalin (40mgPre&Post), preoperative and postoperative 60mg Crisugabalin (60mgPre&Post) and placebo. The primary endpoint was total morphine dose in the 24 h postoperative period.
Results A total of 235 subjects from 20 institutions were randomized to receive Crisugabalin groups and placebo group (figure 1). Morphine consumption within 24 h after surgery was 9.9±8.2mg, 10.3±8.8mg, 9.7±10.1mg and 15.7±12.1mg for Crisugabalin 60mgPre, 40mgPre&Post, 60mgPre&Post and placebo group, showing statistical significance for Crisugabalin groups versus placebo group (P=0.0239, P=0.0261 and P=0.0076, respectively, table 1). Except that the incidence of dizziness and somnolence in Crisugabalin groups were higher than in the placebo group, there were similar types and incidence of TEAEs related to these groups, and most TEAEs were mild to moderate, and spontaneously resolved without necessitating interventions.
The flow of patients during the trial
Conclusions The trial demonstrated that Crisugabalin reduced postoperative opioid consumption, and well tolerated for the treatment of perioperative analgesia in patients undergoing orthopedic surgery.