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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811991
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Post-operative Analgesia Drug: Paracetamol injection Drug: Normal Saline injection Drug: Morhpine PCA Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 348 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2016
Actual Primary Completion Date : September 14, 2018
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Experimental:Paracetamol Injection
325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment
Drug: Paracetamol injection
325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time≥15min.

Drug: 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.

Placebo Comparator: Placebo:Normal Saline Injcetion
32.5mLor 50mL iv q6h according to assignment.
Drug: Normal Saline injection
32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time≥15min.

Drug: 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.




Primary Outcome Measures :
  1. Total morphine use in 24 hours [ Time Frame: 24h after the 1st dose of study drug ]
    Total morhpine use(including PCA and emergency morphine use)in 24 hours.


Secondary Outcome Measures :
  1. Pain Intensity VAS AUC(0-24h) at rest [ Time Frame: 0-24h PI VAS AUC(mesured at 1h、3h、6h、12h、24h after the 1st dose of study drug) ]
  2. Pain Intensity VAS AUC(0-24h) at movement [ Time Frame: 0-24h PI VAS AUC(mesured at 1h、3h、6h、12h、24h after the 1st dose of study drug) ]
  3. Incidence of mophine-related ADR [ Time Frame: 0-24h after the 1st dose of study drug ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811991


Locations
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China, Beijing
Beijing Chao-Yang Hospital
Beijing, Beijing, China, 100020
Beijing Friendship Hospital
Beijing, Beijing, China, 100050
Beijing Hospital
Beijing, Beijing, China, 100730
China, Chongqing
The South West Hospital
Chongqing, Chongqing, China, 400042
China, Fujian
Fuzhou General Hospital of Nanjing Millitary Command
Fuzhou, Fujian, China, 350025
China, Guangxi
Liuzhou General Hospital
Liuzhou, Guangxi, China, 545006
China, Guizhou
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 551100
China, Hebei
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050051
China, Hunan
the Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
No.1 People's Hospital of Chenzhou City
Chenzhou, Hunan, China, 423000
China, Jiangsu
Affiliated Hospital,Jiangnan University
Wuxi, Jiangsu, China, 214062
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
China, Shanghai
Tongji Hospital Affiliated to Tongji University
Shanghai, Shanghai, China, 200065
China, Sichuan
West China Hospital
Chendu, Sichuan, China, 610041
China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300052
China, Zhejiang
Ningbo No.2 Hospital
Ningbo, Zhejiang, China, 315010
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Fei Liu, Ph.D West China Hospital
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02811991    
Other Study ID Numbers: HR-DYXAJF-Ⅲ
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
paracetamol
post-operative analgesia
Additional relevant MeSH terms:
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Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics