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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
264
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.
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.
Shijiazhuang Yiling Pharmaceutical Co.,Ltd
Shijiazhuang, Hebei, China
24 hours (h) total morphine consumption
The total amount of morphine within 24 hours after the end of first drug administration
Time frame: up to 24 hours after multi-dose
Area under the pain intensity curve during movement (AUCM)
Pain intensity under movement Pain intensity under movement
Time frame: 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)
Pain intensity under rest
Time frame: 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
Time frame: 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
Time frame: up to 24 hours after multi-dose
The proportion of morphine used to remedy analgesia.
The proportion of morphine used to remedy analgesia.
Time frame: up to 24 hours after multi-dose
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