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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
235
Subjects will be given 40mg or 60mg of HSK16149 orally.
Subjects will be given HSK16149 placebo orally.
Dongguan People's Hospital
Dongguan, Guangdong, China
Foshan Fuxing Chancheng Hospital
Foshan, Guangdong, China
Morphine Consumption
IV Patient Controlled Analgesia (PCA) morphine for pain management in the immediate postoperative period for an average of 24 hours after surgery. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator. Total morphine consumption = PCA morphine consumption + rescue analgesia morphine consumption.
Time frame: Participants received PCA pump, an average of 24 hours after surgery
NRS at rest and during exercise
NRS:0 (no pain) to 10 (worst possible pain)
Time frame: 1, 2, 6, 12, 18, and 24 hours after surgery
Time of first rescue analgesia with morphine after surgery
Time frame: Within 24 hours after surgery
Incidence of adverse reactions associated with morphine
Time frame: Within 24 hours after surgery
The frequency of rescue analgesia with morphine
Time frame: Within 24 hours after surgery
The total number of PCA presses and the number of effective PCA presses
Time frame: Within 24 hours after surgery
Daily Sleep Interference Scale (DSIS)
Subjects review their sleep status during the past 12 hours at 8:00 a.m. on the day of surgery. DSIS: 0 (not affecting sleep) to 10 (unable to sleep)
Time frame: Within 24 hours after surgery
Subjects analgesic satisfaction score
Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)
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The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Beijing Jishuitan Hospital Guizhou Hospital
Guiyang, Guizhou, China
Zunyi University Affiliated Hospital
Zunyi, Guizhou, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
People's Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
Xiangya Third Hospital of Central South University
Changsha, Hunan, China
...and 11 more locations
Time frame: Within 24 hours after surgery
Investigators analgesic satisfaction score
Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)
Time frame: Within 24 hours after surgery
Number of participants with treatment-related adverse events(TEAE) as assessed by CTCAE v5.0.
Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs)(including QT Interval,QTc Interval and PR Interval), and vital signs.
Time frame: From enrollment to 72 hours after surgery