A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia

Post-operative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811991
• Other study ID #: HR-DYXAJF-?
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2016
• Est. completion date: May 2019

Study information

• Verified date: November 2019
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 348
• Est. completion date: May 2019
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Post-operative Analgesia

Intervention

Drug:
• Paracetamol injection
325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time=15min.
• Normal Saline injection
32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time=15min.
• Morhpine PCA
Morphine PCA will be connected upon the first dose of study drug(roughly 30min prior to the completion of would suture). Morphine PCA is set as follows:1mg bolus every 5min with background infusion of 0.25mg/h and maximal dose<25mg/4h.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	the Third Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital	Chendu	Sichuan
China	No.1 People's Hospital of Chenzhou City	Chenzhou	Hunan
China	The South West Hospital	Chongqing	Chongqing
China	Fuzhou General Hospital of Nanjing Millitary Command	Fuzhou	Fujian
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	Liuzhou General Hospital	Liuzhou	Guangxi
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Tongji Hospital Affiliated to Tongji University	Shanghai	Shanghai
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Affiliated Hospital,Jiangnan University	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine use in 24 hours	Total morhpine use(including PCA and emergency morphine use)in 24 hours.	24h after the 1st dose of study drug
Secondary	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)
Secondary	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)
Secondary	Incidence of mophine-related ADR		0-24h after the 1st dose of study drug