NCT02811991已完成2 期
A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia-Multicentered, Randomized, Double-blind, Placebo-controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 348
- 试验地点
- 16
- 主要终点
- Total morphine use in 24 hours
研究概览
简要总结
Paracetamol,a classical analgesic agent,constitutes an essential component of multi-modal analgesia. This medication is generally safe, well tolerated and effective within recommended daily dose.The purpose of the study is to evaluate the efficacy and safety of Paracetamol Injection as adjuvant to morphine-based post-operative analgesia, as well as to explore the reasonable dosage of paracetamol among Chinese population under above-mentioned circumstance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 to 70 years inclusively, male or female;
- •Patients scheduled for open abdominal surgery(such as gall bladder, lower abdominal investigative surgery), gynecologic surgery(such as trans-abdominal hysterectomy), orthopedic surgery(such as replacement and reconstruction of knee, hip or shoulder joint), with anticipated need for post-operative iv. morphine analgesia≥24h;
- •18kg/m2≤BMI≤30 kg/m2;
- •Classified as ASA risk class I, II according to the American Society of Anesthesiologists;
- •Able to understand the study procedures and the use of the pain scales, able to operate a patient controlled analgesia (PCA) device and to communicate meaningfully with the study observer and staff;
- •Patients free of any contraindication to the study drugs, morphine and to the standardized anesthesia protocol;
- •Clearly understand the procedure of study, voluntarily participate and provided written consent form.
排除标准
- •Impaired liver function (ALT and/or AST > 2 x upper limit of normal range, or TBIL≥1.5 x upper limit of normal range);
- •Impaired renal function(Serum Creatinine >176μmoL/L), or undergoing dialysis within 28 days before surgery;
- •Patients at high risk for bleeding, including congenital hemorrhagic disease(such as Hemophilia), Thrombocytopenia(CBC PLT<30×109/L), Qualitative Plateletdefects(such as ITP, DIC, congenital abonormal platelet), or clinically significant active bleeding;
- •Abnormal resting ECG, judged as not eligible for entry by investigator;
- •Hypertensive patients not achieving satisfactory BP control under hypertensive medication(Sitting SBP≥160mm Hg, and/or DBP≥105mm Hg during screen period);
- •Sitting SBP≤90mm Hg during screening period;
- •Diabetic Patients not achieving satisfactory blood glucose control(FBG≥11.1moL/L during screening period);
- •Known history of bronchial asthma, pulmonary heart disease or heart failure;
- •Participation in other trials within 30 days;
- •Pregnant women or women in lactation;
- •Patients not eligible due to other reasons judged by the investigator.
研究组 & 干预措施
Experimental:Paracetamol Injection
Active Comparator
325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment
干预措施: Paracetamol injection (Drug)
Experimental:Paracetamol Injection
Active Comparator
325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment
干预措施: Morhpine PCA (Drug)
Placebo:Normal Saline Injcetion
Placebo Comparator
32.5mLor 50mL iv q6h according to assignment.
干预措施: Normal Saline injection (Drug)
Placebo:Normal Saline Injcetion
Placebo Comparator
32.5mLor 50mL iv q6h according to assignment.
干预措施: Morhpine PCA (Drug)
结局指标
主要结局
Total morphine use in 24 hours
时间窗: 24h after the 1st dose of study drug
Total morhpine use(including PCA and emergency morphine use)in 24 hours.
次要结局
- Pain Intensity VAS AUC(0-24h) at rest(0-24h PI VAS AUC(mesured at 1h、3h、6h、12h、24h after the 1st dose of study drug))
- Pain Intensity VAS AUC(0-24h) at movement(0-24h PI VAS AUC(mesured at 1h、3h、6h、12h、24h after the 1st dose of study drug))
- Incidence of mophine-related ADR(0-24h after the 1st dose of study drug)
研究者
研究点 (16)
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