Post-operative AnalgesiaPhase 2/3NCT02811991
A PhaseⅡ/ Ⅲ Seamless Study to Evaluate Efficacy and Safety of Paracetamol Injection as Adjuvant to Morphine-based Postoperative Analgesia
A Phase 2/3 study testing Paracetamol injection, Normal Saline injection and Morhpine PCA in people with Post-operative Analgesia, run by Jiangsu HengRui Medicine Co., Ltd. at 16 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-operative Analgesia
- What is being tested?
- Paracetamol injection, Normal Saline injection and Morhpine PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 16 sitesChina
- Study dates
- Jun 2016to May 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, 100020
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Beijing Hospital
Beijing, Beijing Municipality, 100730
The First Hospital of Jilin University
Changchun, Jilin, 130021
the Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
West China Hospital
Chengdu, Sichuan, 610041
No.1 People's Hospital of Chenzhou City
Chenzhou, Hunan, 423000
The South West Hospital
Chongqing, Chongqing Municipality, 400042
Fuzhou General Hospital of Nanjing Millitary Command
Fuzhou, Fujian, 350025
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 551100
Liuzhou General Hospital
Liuzhou, Guangxi, 545006
Ningbo No.2 Hospital
Ningbo, Zhejiang, 315010
Tongji Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200065
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Affiliated Hospital,Jiangnan University
Wuxi, Jiangsu, 214062
About this study
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
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
- Post-operative Analgesia
- Being tested
- Paracetamol injection, Normal Saline injection, Morhpine PCA
- Keywords
- paracetamol, post-operative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol injectionDrug
325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time≥15min.
Normal Saline injectionDrug
32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time≥15min.
Morhpine PCADrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental:Paracetamol Injection | Active comparator | 325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment Receives: Drug: Paracetamol injection; Drug: Morhpine PCA |
| Placebo:Normal Saline Injcetion | Placebo comparator | 32.5mLor 50mL iv q6h according to assignment. Receives: Drug: Normal Saline injection; Drug: Morhpine PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine use in 24 hours
Total morhpine use(including PCA and emergency morphine use)in 24 hours.
Measured: 24h after the 1st dose of study drug
Secondary outcomes (3)
Pain Intensity VAS AUC(0-24h) at rest
Measured: 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
Measured: 0-24h PI VAS AUC(mesured at 1h、3h、6h、12h、24h after the 1st dose of study drug)
Incidence of mophine-related ADR
Measured: 0-24h after the 1st dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion14 Sep 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Liu, Ph.D, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811991
- Sponsor's protocol ID
- HR-DYXAJF-Ⅲ
- Status last verified
- Nov 2019
- First submitted
- 21 Jun 2016
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02811991
- Acronym / sponsor ID
- HR-DYXAJF-Ⅲ
- Conditions
- Post-operative Analgesia
- Keywords
- paracetamol, post-operative analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:Paracetamol Injection | Active comparator | Drug: Paracetamol injection, Drug: Morhpine PCA325mg(32.5mL)or 500mg(50mL) iv q6h according to assignment |
| Placebo:Normal Saline Injcetion | Placebo comparator | Drug: Normal Saline injection, Drug: Morhpine PCA32.5mLor 50mL iv q6h according to assignment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol injection325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time≥15min. | Drug | Experimental:Paracetamol Injection |
| Normal Saline injection32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time≥15min. | Drug | Placebo:Normal Saline Injcetion |
| Morhpine PCAMorphine 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. | Drug | Experimental:Paracetamol Injection, Placebo:Normal Saline Injcetion |
Primary outcome
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.
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Derived from this study: PubMed 35935863Yin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fei Liu, Ph.D principal investigator
West China Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Paracetamol injection, Normal Saline injection and Morhpine PCA in people with Post-operative Analgesia, run by Jiangsu HengRui Medicine Co., Ltd. at 16 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine use in 24 hours (time frame: 24h after the 1st dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02811991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.