Postsurgical Pain
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.
Interventions
SHR0410 Injection
DRUGPlacebo for SHR0410 Injection
SHR0410 Injection blank preparation
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
SHR0410 Injection compared with placebo
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 general anesthesia orthopedic surgery； 3. Male or female； 4. Meet the body mass index standard； 5. Conform to the ASA Physical Status Classification； 6. Negative pregnancy test.
Exclusion criteria
1. Subjects with a history of myocardial infarction or unstable angina pectoris； 2. Subjects with atrioventricular block or cardiac insufficiency； 3. Subjects with a history of malignancy ； 4. Subjects with a history of stroke； 5. Subjects with a history of mental illness； 6. Subjects with a history of difficult airway； 7. Random blood glucose ≥11.1mmol/L； 8. Subjects with poor blood pressure control； 9. Abnormal values in liver or renal function； 10. Subject with a history of substance abuse and drug abuse； 11. Allergic to drugs that may be used during the study； 12. Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives； 13. Participated in clinical trials of other drugs (received experimental drugs)； 14. Other circumstances that the investigator judged inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage of Morphine, Post Surgery | 0 hour to 48 hours after IP administration | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 48 hour period post IP administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition | 48-hours | Pain intensity will be evaluated using an 11-point (0-10) Numeric Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NRS. |
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition | 48-hours | Pain intensity will be evaluated using an 11-point (0-10) Numeric Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NRS. |
| Time to First Dose of Rescue Analgesia | 0 hour to 48 hours after IP administration | Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. |
| Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject | 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration | Rescue analgesia was available to subjects with inadequately controlled pain upon request. |
| Usage of Morphine, Post Surgery at other intervals | 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-24 hours after IP administration.Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 4-48 hours after IP administration. |
| Proportion of subjects who did not receive Rescue Analgesia | 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration | Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. |
| Participant ' satisfaction score for analgesia treatment | 48-hours | Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied. |
| Investigator satisfaction score for analgesia treatment | 48-hours | Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied |
| Total press times of PCA pump and effective press times of PCA pump | 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration | Read and record the press times and effective press times from PCA |
Countries
China
Outcome results
None listed