The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
199
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Safety:Incidence and severity of AE/SAE
Time frame: from ICF signing date to day 12 since last dose(14 days)
the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition
Time frame: 48hours
The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication
Time frame: 48hours
Participant ' satisfaction score for analgesia treatment
Time frame: 48hours
Investigator satisfaction score for analgesia treatment
Time frame: 48hours
Time of first use of remedial analgesic medication
Time frame: 48hours
Cumulative use of remedial analgesics
Time frame: 48hours
Cmax
Time frame: 5 days
Tmax
Time frame: 5 days
AUC0-12h
Time frame: 5 days
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