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Adjustment of R&D strategy
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0410 Injection High dose | Experimental |
| |
| SHR0410 Injection Low dose | Experimental |
| |
| Placebo for SHR0410 Injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0410 Injection | Drug | SHR0410 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Usage of Morphine, Post Surgery | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 48 hour period post IP administration | 0 hour to 48 hours after IP administration |
| Measure | Description | Time Frame |
|---|---|---|
| Usage of Morphine, Post Surgery at other intervals | 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. | 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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SHR0410 Injection compared with placebo
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| Placebo for SHR0410 Injection | Drug | SHR0410 Injection blank preparation |
|
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition | 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. | 48-hours |
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition | 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. | 48-hours |
| Time to First Dose of Rescue Analgesia | 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. | 0 hour to 48 hours after IP administration |
| Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject | Rescue analgesia was available to subjects with inadequately controlled pain upon request. | 0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration |
| Total press times of PCA pump and effective press times of PCA pump | Read and record the press times and effective press times from PCA | 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 subjects who did not receive Rescue Analgesia | Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of 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 |
| Participant ' satisfaction score for analgesia treatment | 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. | 48-hours |
| Investigator satisfaction score for analgesia treatment | Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied | 48-hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |