This is a multi-center, randomized, double-blind, placebo/active-controlled study. 405 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK21542 group, morphine group, and placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
405
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Sum of Pain Intensity Differences (SPID)
Sum of Pain Intensity Differences (SPID) of each group
Time frame: 48 hours
Proportion of subjects experiencing nausea
Proportion of subjects experiencing nausea of each group
Time frame: 48 hours
Proportion of subjects experiencing vomit
Proportion of subjects experiencing vomit of each group
Time frame: 48 hours
Sum of Pain Intensity Differences (SPID) in other time frame
Sum of Pain Intensity Differences (SPID) in other time frame
Time frame: 0-8 hours, 0-24 hours, 24-48 hours
Number of times rescue analgesic medications were administered.
Number of times rescue analgesic medications were administered.
Time frame: 48 hours
Total morphine consumption
Total morphine consumption of each group
Time frame: 48 hours
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