HSK16149 for Perioperative Analgesia in Orthopedic Surgery

Status Completed

Clinical Trial Summary

This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.

Clinical Trial Description

This study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h. Subjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period. Subjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator. After the treatment period, the subjects will be followed up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06007066
Study type	Interventional
Source	Haisco Pharmaceutical Group Co., Ltd.
Contact
Status	Completed
Phase	Phase 2
Start date	March 8, 2023
Completion date	July 5, 2023

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