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A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial on the efficacy and safety of felbinac trometamol Injection in the treatment of moderate and severe postoperative pain.main purpose is to evaluate the efficacy of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and severe pain after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: group1 | Experimental | Generic name: Felbinac Trometamol Injection; Placebo:Normal saline Dosage form: Injection Dosage:8ml Volume:4ml |
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| Experimental: group2 | Placebo Comparator | Generic name:Placebo Placebo:Normal saline Dosage form:Injection Dosage:8mg Volume:4ml |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Felbinac Trometamol Injection | Drug | Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).. One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 24h total morphine consumption | The total amount of morphine within 24 hours after the end of first drug administration | up to 24hours after multi-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the pain intensity curve during movement (AUCM) | Pain intensity under movement | 0-8 h,8-16 h,16-24 h and 0-48 h |
| Area under the pain intensity curve during rest(AUCR) | Pain intensity under rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen Ouyang, MD | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shijiazhuang Yiling Pharmaceutical Co.,Ltd | Shijiazhuang | Hebei | 050036 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebos | Drug | Placebo diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min). One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours. |
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| 0-8 h,8-16 h,16-24 h and 0-48 h |
| Pain intensity at 48 hours after the end of the first administration under movement | up to 48 hours after multi-dose |
| Pain intensity at 48 hours after the end of the first administration under rest | up to 48 hours after multi-dose |
| Press time | The first time to press the analgesic pump for analgesia | up to 48 hours after multi-dose |
| Total and effective pressing times of analgesic pump | up to 24 and 48 hours after multi-dose |
| The proportion of morphine used to remedy analgesia | up to 24 and 48 hours after multi-dose |
| Total amount of morphine administered within 48 hours after the first administration | up to 48 hours after multi-dose |