CompletedNCT02811991Updated Nov 5, 2019

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

A Phase 2/3 interventional study of Paracetamol injection and Normal Saline injection in Post-operative Analgesia, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 16 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-11-05.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 348
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Post-operative Analgesia

Browse trials for

Agnosia 1,190

Keywords

paracetamol
post-operative analgesia

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 348 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.

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Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 348 participants (actual)

Study arms

Active comparator
Experimental:Paracetamol Injection
325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment
Drug: Paracetamol injection · Drug: Morhpine PCA
Placebo comparator
Placebo:Normal Saline Injcetion
32.5mLor 50mL iv q6h according to assignment.
Drug: Normal Saline injection · Drug: Morhpine PCA

Interventions

DrugParacetamol injection
325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time≥15min.
DrugNormal Saline injection
32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time≥15min.
DrugMorhpine 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.

What researchers measure

Primary outcomes

Total morphine use in 24 hours
Total morhpine use(including PCA and emergency morphine use)in 24 hours.
Time frame: 24h after the 1st dose of study drug

Secondary outcomes

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)
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)
Incidence of mophine-related ADR
Time frame: 0-24h after the 1st dose of study drug

Study locations

16 sites

Beijing Chao-Yang Hospital
Beijing, Beijing 100020, China
Beijing Friendship Hospital
Beijing, Beijing 100050, China
Beijing Hospital
Beijing, Beijing 100730, China
The South West Hospital
Chongqing, Chongqing 400042, China
Fuzhou General Hospital of Nanjing Millitary Command
Fuzhou, Fujian 350025, China
Liuzhou General Hospital
Liuzhou, Guangxi 545006, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou 551100, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei 050051, China
the Third Xiangya Hospital of Central South University
Changsha, Hunan 410013, China
No.1 People's Hospital of Chenzhou City
Chenzhou, Hunan 423000, China
Affiliated Hospital,Jiangnan University
Wuxi, Jiangsu 214062, China
The First Hospital of Jilin University
Changchun, Jilin 130021, China
Tongji Hospital Affiliated to Tongji University
Shanghai, Shanghai 200065, China
West China Hospital
Chendu, Sichuan 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin 300052, China
Ningbo No.2 Hospital
Ningbo, Zhejiang 315010, China

References and documents

Publications

Yin F, Ma W, Liu Q, Xiong LL, Wang TH, Li Q, Liu F. Efficacy and safety of intravenous acetaminophen (2 g/day) for reducing opioid consumption in Chinese adults after elective orthopedic surgery: A multicenter randomized controlled trial. Front Pharmacol. 2022 Jul 22;13:909572. doi: 10.3389/fphar.2022.909572. eCollection 2022. PubMed 35935863 ↗

Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02811991
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible party: Sponsor
First posted: Jun 23, 2016
Start date: Jun 2016
Primary completion: Sep 14, 2018
Completion: May 2019
Last update: Nov 5, 2019

Study contacts

Fei Liu, Ph.D

principal investigator · West China Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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