Nalbuphine AllergyPhase 4NCT05073744
Nalbuphine Versus Morphine for Perioperative Tumor Ablation
A Phase 4 study testing Nalbuphine and Morphine in people with Nalbuphine Allergy and Ablation, run by Zhongda Hospital at 20 sites in China.
Trial summary
This randomized, positive control, multicentre trial is designed to compare the analgesic efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative tumor ablation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nalbuphine Allergy, Ablation, Safety
- What is being tested?
- Nalbuphine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 20 sitesChina
- Study dates
- 5 Sep 2021to 31 Aug 2023
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring tumor ablation;
- Voluntarily participate and sign the informed consent.
Who cannot join
- Allergic to contrast agent, test drug or other ingredients;
- With a history of substance abuse, chronic pain and mental illness;
- Use of any monamine oxidase inhibitor within 14 days prior to randomization;
- Pregnant or breastfeeding;
- Cannot tolerate ablation due to other reasons;
- Cannot express their wishes correctly;
Show all 9Show fewer
- Poor compliance, unable to complete the trial;
- Have participated in other drug trials within 30 days prior to enrollment;
- Judged by the researcher to be unsuitable.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites, 20 recruiting
- Not yet recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
- Not yet recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
- Not yet recruiting
Anhui Province Cancer Hospital
Hefei, Anhui
- Not yet recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui
- Not yet recruiting
Jingmen NO.2People's Hospital
Jingmen, Hubei
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
- Not yet recruiting
Lishui Municipal Central Hospital
Lishui, Zhejiang
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
- Not yet recruiting
Guangxi Medical University Affiliated Tumor Hospita
Nanning, Guangxi
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
- Not yet recruiting
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
- Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
- Not yet recruiting
Shengjing Hospital of China Medical University
Shengyang, Liaoning
- Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
- Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
- Not yet recruiting
Yichang Central People's Hospital
Yichang, Hubei
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial
This randomized, positive control, multicentre trial is designed to compare the analgesic efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative tumor ablation.
Read the detailed description
Sedation and analgesia use in tumor ablation is a necessary part of the procedure. However, the optimal medicine for sedation and analgesia for tumor ablation remains controversial. Currently, morphine is a traditional opioid used for pain control and anaesthesia. As no publications have compared the anaesthetic and analgesic effects between nalbuphine and morphine during tumor ablation, this trial aims to compare the analgesic efficacy and safety of nalbuphine and morphine for perioperative tumor ablation. In addition, other endpoints in term of perioperative analgesia indexes, such as ablation time, daily dose, analgesia satisfaction, quality of life, and safety, etc. will be compared.
- Conditions
- Nalbuphine Allergy, Ablation, Safety
- Being tested
- Nalbuphine, Morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NalbuphineDrug
Also called Tumor ablation using nalbuphine
Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation
MorphineDrug
Also called Tumor ablation using morphine
Morphine hydrochloride injection is used for perioperative tumor ablation
| Study group | Role | What they receive |
|---|---|---|
| Tumor ablation using nalbuphine for pain control and anaesthesia | Experimental | Nalbuphine hydrochloride injection (80mg) plus 0.9% saline are combined into 80 ml self-controlled analgesic pump, which will be run 25minutes before ablation under Electrocardiogram monitoring. Single pressure administration if numerical rating scale≥4 points. Receives: Drug: Nalbuphine |
| Tumor ablation using morphine for pain control and anaesthesia | Active comparator | Morphine hydrochloride injection (80mg) plus 0.9% saline are combined into 80 ml self-controlled analgesic pump, which will be run 25minutes before ablation under Electrocardiogram monitoring. Single pressure administration if numerical rating scale≥4 points. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic efficiency
No. effective cases / No.Total cases * 100%. The numerical rating scale score at the evaluation time point (at rest) ≤3 is considered as effective analgesia.
Measured: From the begin to 48 hours after procedure
Secondary outcomes (7)
Pain intensity
Pain assessment using the numerical rating scale (NRS), which is composed of 11 numbers spaced from 0 to 10, with 0 representing "no pain" and 10 representing "most intense pain". Patients chose 1 number to represent their pain intensity.
Measured: From the begin to 48 hours after procedure
Analgesia satisfaction
Scored using visual analogue scale, a 10 cm long scale, marked with 10 markers, both ends of 0 point and 10 points respectively. Participant and medical care personnel mark the corresponding position on a ruler that represents their satisfaction. A score of 0 represents extremely dissatisfied and a score of 10 represents very satisfied.
Measured: Up to 4 hours
Duration of ablation
Duration of the whole procedure
Measured: Up to 4 hours
Postoperative hospital stay
Days from the time of ablation to Discharge time
Measured: Up to 10 days
Rate of continuous ablation without complaining of pain
No. ablation without complaining of pain cases / No.Total cases * 100%
Measured: Up to 4 hours
Average daily dosage
Total dose of nalbuphine or morphine / Total days of analgesia
Measured: From nalbuphine/morphine use to 48 hours after procedure
Health-related quality of life
Assessed by telephone, using the standard of Quality of Life Question-Core by the European O-Rganization for Reasearch and Treatment of Cancer (EORTC QLQ-C30 scale,Version 3.0). The evaluation of quality of life from a multi-dimensional perspective can better reflect the connotation of quality of life, which has been applied to measure QOL of cancer patients in many countries and regions. A total of 30 questions will be replied with different points. Higher score represents lower quality of life.
Measured: 7 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start5 Sep 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nalbuphine AllergyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-Jun Teng, MD, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073744
- Sponsor's protocol ID
- NPRCT001
- Status last verified
- Dec 2022
- First submitted
- 6 Sep 2021
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Other researchers can contact the PI for data.
Publications
Laurent G, Bertaux G, Martel A, Fraison M, Fromentin S, Gonzalez S, Pierre FS, Wolf JE. A randomized clinical trial of continuous flow nitrous oxide and nalbuphine infusion for sedation of patients during radiofrequency atrial flutter ablation. Pacing Clin Electrophysiol. 2006 Apr;29(4):351-7. doi: 10.1111/j.1540-8159.2006.00352.x.
PubMed 16650261Sun S, Guo Y, Wang T, Huang S. Analgesic Effect Comparison Between Nalbuphine and Sufentanil for Patient-Controlled Intravenous Analgesia After Cesarean Section. Front Pharmacol. 2020 Nov 16;11:574493. doi: 10.3389/fphar.2020.574493. eCollection 2020.
PubMed 33364949Yu P, Zhang J, Wang J. Nalbuphine for spinal anesthesia: A systematic review and meta-analysis. Pain Pract. 2022 Jan;22(1):91-106. doi: 10.1111/papr.13021. Epub 2021 Jun 2.
PubMed 33887111Xue Y, Huang Z, Cheng B, Sun J, Zhu H, Tang Y, Wang X. Analgesic efficacy and safety of nalbuphine versus morphine for perioperative tumor ablation: a randomized, controlled, multicenter trial. Trials. 2022 Oct 22;23(1):887. doi: 10.1186/s13063-022-06825-5.
PubMed 36273202
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial
- ClinicalTrials.gov ID
- NCT05073744
- Acronym / sponsor ID
- NPRCT001
- Conditions
- Nalbuphine Allergy, Ablation, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 5 Sep 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 11 Oct 2021 (actual)
- 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.
This randomized, positive control, multicentre trial is designed to compare the analgesic efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative tumor ablation.
Detailed description
Sedation and analgesia use in tumor ablation is a necessary part of the procedure. However, the optimal medicine for sedation and analgesia for tumor ablation remains controversial. Currently, morphine is a traditional opioid used for pain control and anaesthesia. As no publications have compared the anaesthetic and analgesic effects between nalbuphine and morphine during tumor ablation, this trial aims to compare the analgesic efficacy and safety of nalbuphine and morphine for perioperative tumor ablation. In addition, other endpoints in term of perioperative analgesia indexes, such as ablation time, daily dose, analgesia satisfaction, quality of life, and safety, etc. will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tumor ablation using nalbuphine for pain control and anaesthesia | Experimental | Drug: NalbuphineNalbuphine hydrochloride injection (80mg) plus 0.9% saline are combined into 80 ml self-controlled analgesic pump, which will be run 25minutes before ablation under Electrocardiogram monitoring. Single pressure administration if numerical rating scale≥4 points. |
| Tumor ablation using morphine for pain control and anaesthesia | Active comparator | Drug: MorphineMorphine hydrochloride injection (80mg) plus 0.9% saline are combined into 80 ml self-controlled analgesic pump, which will be run 25minutes before ablation under Electrocardiogram monitoring. Single pressure administration if numerical rating scale≥4 points. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients requiring tumor ablation;
- Voluntarily participate and sign the informed consent.
Key exclusion criteria (9 listed)
- Allergic to contrast agent, test drug or other ingredients;
- With a history of substance abuse, chronic pain and mental illness;
- Use of any monamine oxidase inhibitor within 14 days prior to randomization;
- Pregnant or breastfeeding;
- Cannot tolerate ablation due to other reasons;
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 |
|---|---|---|
| NalbuphineAlso: Tumor ablation using nalbuphineNalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation | Drug | Tumor ablation using nalbuphine for pain control and anaesthesia |
| MorphineAlso: Tumor ablation using morphineMorphine hydrochloride injection is used for perioperative tumor ablation | Drug | Tumor ablation using morphine for pain control and anaesthesia |
Primary outcome
Analgesic efficiency
Time frame: From the begin to 48 hours after procedure
No. effective cases / No.Total cases * 100%. The numerical rating scale score at the evaluation time point (at rest) ≤3 is considered as effective analgesia.
7 secondary outcomes
Pain intensity
Time frame: From the begin to 48 hours after procedure
Analgesia satisfaction
Time frame: Up to 4 hours
Duration of ablation
Time frame: Up to 4 hours
Postoperative hospital stay
Time frame: Up to 10 days
Rate of continuous ablation without complaining of pain
Time frame: Up to 4 hours
Average daily dosage
Time frame: From nalbuphine/morphine use to 48 hours after procedure
Health-related quality of life
Time frame: 7 days after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Background: PubMed 16650261Laurent G, Bertaux G, Martel A, Fraison M, Fromentin S, Gonzalez S, Pierre FS, Wolf JE. A randomized clinical trial of continuous flow nitrous oxide and nalbuphine infusion for sedation of patients during radiofrequency atrial flutter ablation. Pacing Clin Electrophysiol. 2006 Apr;29(4):351-7. doi: 10.1111/j.1540-8159.2006.00352.x.
- Background: PubMed 33364949Sun S, Guo Y, Wang T, Huang S. Analgesic Effect Comparison Between Nalbuphine and Sufentanil for Patient-Controlled Intravenous Analgesia After Cesarean Section. Front Pharmacol. 2020 Nov 16;11:574493. doi: 10.3389/fphar.2020.574493. eCollection 2020.
- Background: PubMed 33887111Yu P, Zhang J, Wang J. Nalbuphine for spinal anesthesia: A systematic review and meta-analysis. Pain Pract. 2022 Jan;22(1):91-106. doi: 10.1111/papr.13021. Epub 2021 Jun 2.
- Derived from this study: PubMed 36273202Xue Y, Huang Z, Cheng B, Sun J, Zhu H, Tang Y, Wang X. Analgesic efficacy and safety of nalbuphine versus morphine for perioperative tumor ablation: a randomized, controlled, multicenter trial. Trials. 2022 Oct 22;23(1):887. doi: 10.1186/s13063-022-06825-5.
- Individual participant dataSharing planned: No. Other researchers can contact the PI for data.
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.
Gao-Jun Teng, MD principal investigator
Zhongda Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nalbuphine and Morphine in people with Nalbuphine Allergy and Ablation, run by Zhongda Hospital at 20 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao-Yan Wang (86 13851821464, xywangseu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic efficiency (time frame: From the begin to 48 hours after procedure). 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 NCT05073744, which also lists 4 linked publications.
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 29 Dec 2022.