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The primary objective is to evaluate the analgesic efficacy of the combination of SHR8554 injection and SHR0410 injection compared with SHR8554 injection in patients with acute postoperative pain following abdominal surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A: SHR8554 Injection and SHR0410 Injection | Experimental |
| |
| Treatment group B: SHR8554 Injection and SHR0410 Injection | Experimental |
| |
| Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8554 Injection and SHR0410 Injection | Drug | Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 24 Hours | Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS. | 24-hours |
| Measure | Description | Time Frame |
|---|---|---|
| the Sum of Pain Intensity Differences in Pain Score Over 6、12、12-24 Hours | time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、12-24 hours) to yield values on the 0-10 NPRS. | 6-hours、12-hours、12-24 hours |
| Time of first use of remedial analgesic medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qin Liu | Contact | +0518-82342973 | qin.liu@hengrui.com |
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Parallel Assignment
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| SHR8554 Injection and SHR0410 Injection | Drug | Treatment group B: SHR8554 Injection and SHR0410 Injection; low dose |
|
| SHR8554 Injection and Placebo for SHR0410 Injection | Drug | Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection |
|
The first time to use remedial analgesic medication for injection |
| 24-hours |
| Cumulative use of remedial analgesics from 0h to 24h | Cumulative use of remedial analgesic medication | 24-hours |
| 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. | 24-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. | 24-hours |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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