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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 postoperative pain in gynecology.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 |
|---|---|---|---|
| group1 | Experimental | Generic name: Felbinac Trometamol Injection; Dosage form: Injection Dosage:94.25mg Volume:4ml Frequency:Multi-dose Duration:1 day. A total of 132 subjects received the test drug . |
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| group2 | Placebo Comparator | Placebo:Normal saline Dosage form:Injection Dosage:0mg Volume:0ml Frequency:Multi-dose Duration:1 day A total of 132 subjects received the placebo. |
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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 and 16h after the start of the first dose,the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hours (h) total morphine consumption | The total amount of morphine within 24 hours after the end of first drug administration | up to 24 hours after multi-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the pain intensity curve during movement (AUCM) | Pain intensity under movement Pain intensity under movement | 1-8 hours (h) ,8-16 h,16-24 (within 24 hours after the end of first drug administration) |
| Area under the pain intensity curve during rest(AUCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mengchang Gao, MD | Sichuan Provincial People's Hospital | 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 and 16h after the start of the first dose, the first intravenous infusion was started at 30±5 minutes before the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day, once every 8 hours. |
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Pain intensity under rest |
| 1-8 hours (h) ,8-16 h,16-24 h(within 24 hours after the end of first drug administration) |
| Press time | The first time to press the analgesic pump for analgesia | up to 24 hours after multi-dose |
| Total and effective pressing times of analgesic pump within 24 hours after the first administration | Total and effective pressing times of analgesic pump within 24 hours after the first administration | up to 24 hours after multi-dose |
| The proportion of morphine used to remedy analgesia. | The proportion of morphine used to remedy analgesia. | up to 24 hours after multi-dose |