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

Primary Purpose

Post-operative Analgesia

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paracetamol injection
Normal Saline injection
Morhpine PCA
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Analgesia focused on measuring paracetamol, post-operative analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chao-Yang Hospital
  • Beijing Friendship Hospital
  • Beijing Hospital
  • The South West Hospital
  • Fuzhou General Hospital of Nanjing Millitary Command
  • Liuzhou General Hospital
  • Guizhou Provincial People's Hospital
  • The Third Hospital of Hebei Medical University
  • the Third Xiangya Hospital of Central South University
  • No.1 People's Hospital of Chenzhou City
  • Affiliated Hospital,Jiangnan University
  • The First Hospital of Jilin University
  • Tongji Hospital Affiliated to Tongji University
  • West China Hospital
  • Tianjin Medical University General Hospital
  • Ningbo No.2 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental:Paracetamol Injection

Placebo:Normal Saline Injcetion

Arm Description

325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment

32.5mLor 50mL iv q6h according to assignment.

Outcomes

Primary Outcome Measures

Total morphine use in 24 hours
Total morhpine use(including PCA and emergency morphine use)in 24 hours.

Secondary Outcome Measures

Pain Intensity VAS AUC(0-24h) at rest
Pain Intensity VAS AUC(0-24h) at movement
Incidence of mophine-related ADR

Full Information

First Posted
June 21, 2016
Last Updated
November 3, 2019
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02811991
Brief Title
A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia
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 Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
September 14, 2018 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Analgesia
Keywords
paracetamol, post-operative analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
348 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental:Paracetamol Injection
Arm Type
Active Comparator
Arm Description
325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment
Arm Title
Placebo:Normal Saline Injcetion
Arm Type
Placebo Comparator
Arm Description
32.5mLor 50mL iv q6h according to assignment.
Intervention Type
Drug
Intervention Name(s)
Paracetamol injection
Intervention Description
325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time≥15min.
Intervention Type
Drug
Intervention Name(s)
Normal Saline injection
Intervention Description
32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time≥15min.
Intervention Type
Drug
Intervention Name(s)
Morhpine PCA
Intervention Description
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 Measure Information:
Title
Total morphine use in 24 hours
Description
Total morhpine use(including PCA and emergency morphine use)in 24 hours.
Time Frame
24h after the 1st dose of study drug
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
Incidence of mophine-related ADR
Time Frame
0-24h after the 1st dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Liu, Ph.D
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Beijing Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The South West Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Fuzhou General Hospital of Nanjing Millitary Command
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Facility Name
Liuzhou General Hospital
City
Liuzhou
State/Province
Guangxi
ZIP/Postal Code
545006
Country
China
Facility Name
Guizhou Provincial People's Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
551100
Country
China
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
the Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
No.1 People's Hospital of Chenzhou City
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Facility Name
Affiliated Hospital,Jiangnan University
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214062
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Tongji Hospital Affiliated to Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200065
Country
China
Facility Name
West China Hospital
City
Chendu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Ningbo No.2 Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35935863
Citation
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.
Results Reference
derived

Learn more about this trial

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

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