Postoperative Pain in Orthopaedics
Conditions
Brief summary
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.
Interventions
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects requiring elective orthopedic surgery 3. Conform to the ASA Physical Status Classification
Exclusion criteria
1. Subjects with a history of severe allergies 2. Subjects with nervous system disease 3. Subjects with a history of mental illness 4. Subjects with abnormal liver and renal function 5. Subjects with poorly controlled hypertensive or hypotensive 6. QTc：\>450ms（male），\>470ms（female） 7. Subjects who screened positive for substance abuse 8. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) 9. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety：Incidence and severity of AE/SAE | from ICF signing date to day 12 since last dose(14 days) |
Secondary
| Measure | Time frame |
|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 6hour、12hour、16hour、24hour、48hour、12hour-24hour、24hour-48hour under static and moving condition | 48hours |
| The response rate of NRS scores under static and moving condition at 24hour and 48hour after the first dose of medication | 48hours |
| Participant ' satisfaction score for analgesia treatment | 48hours |
| Investigator satisfaction score for analgesia treatment | 48hours |
| Time of first use of remedial analgesic medication | 48hours |
| Cumulative use of remedial analgesics | 48hours |
| Cmax | 5 days |
| Tmax | 5 days |
| AUC0-12h | 5 days |
Countries
China
Outcome results
None listed