Phase III Study of HSK21542 Injection Compared to Morphine and Placebo for Treating Postoperative Pain After Orthopedic Surgery

What this Trial Is About

Researchers are evaluating the efficacy and safety of HSK21542 injection for managing postoperative pain in patients undergoing orthopedic surgery. This is a Phase III, multi-center, randomized, double-blind, placebo and active-controlled study involving 405 participants. The trial compares HSK21542, morphine, and placebo to understand their effects on pain relief after surgery. Participants will be randomly assigned to receive either HSK21542, morphine, or a placebo. The study treatments are administered following surgery under general anesthesia, specifically for patients undergoing hip replacement. The trial monitors pain intensity and other effects over a 48-hour period post-treatment. During the study, participants will be assessed for pain relief using the Sum of Pain Intensity Differences SPID at 48 hours as the primary measure. Secondary measures include nausea and vomiting occurrence, additional pain assessments at shorter intervals, rescue medication use, and total morphine consumption. Safety and effectiveness will be closely monitored throughout the trial lasting until March 2026.

A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment in Orthopedic Surgery