A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia
- Conditions
- Post-operative Analgesia
- Interventions
- Registration Number
- NCT02811991
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 348
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo:Normal Saline Injcetion Morhpine PCA 32.5mLor 50mL iv q6h according to assignment. Experimental:Paracetamol Injection Paracetamol injection 325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment Experimental:Paracetamol Injection Morhpine PCA 325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment Placebo:Normal Saline Injcetion Normal Saline injection 32.5mLor 50mL iv q6h according to assignment.
- Primary Outcome Measures
Name Time Method Total morphine use in 24 hours 24h after the 1st dose of study drug Total morhpine use(including PCA and emergency morphine use)in 24 hours.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (16)
Fuzhou General Hospital of Nanjing Millitary Command
🇨🇳Fuzhou, Fujian, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, Guizhou, China
No.1 People's Hospital of Chenzhou City
🇨🇳Chenzhou, Hunan, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
West China Hospital
🇨🇳Chendu, Sichuan, China
Ningbo No.2 Hospital
🇨🇳Ningbo, Zhejiang, China
Affiliated Hospital,Jiangnan University
🇨🇳Wuxi, Jiangsu, China
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
the Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Liuzhou General Hospital
🇨🇳Liuzhou, Guangxi, China
Beijing Chao-Yang Hospital
🇨🇳Beijing, Beijing, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
Tongji Hospital Affiliated to Tongji University
🇨🇳Shanghai, Shanghai, China
The South West Hospital
🇨🇳Chongqing, Chongqing, China