Nalbuphine Versus Morphine for Perioperative Tumor Ablation
Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial
1 other identifier
interventional
316
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2021
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 5, 2021
CompletedFirst Submitted
Initial submission to the registry
September 6, 2021
CompletedFirst Posted
Study publicly available on registry
October 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedDecember 29, 2022
December 1, 2022
2 years
September 6, 2021
December 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From the begin to 48 hours after procedure
Secondary Outcomes (7)
Pain intensity
From the begin to 48 hours after procedure
Analgesia satisfaction
Up to 4 hours
Duration of ablation
Up to 4 hours
Postoperative hospital stay
Up to 10 days
Rate of continuous ablation without complaining of pain
Up to 4 hours
- +2 more secondary outcomes
Other Outcomes (1)
Safety end point
From nalbuphine/morphine use to 48 hours after procedure
Study Arms (2)
Tumor ablation using nalbuphine for pain control and anaesthesia
EXPERIMENTALNalbuphine 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 COMPARATORMorphine 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.
Interventions
Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation
Morphine hydrochloride injection is used for perioperative tumor ablation
Eligibility Criteria
You may qualify if:
- Patients requiring tumor ablation;
- Voluntarily participate and sign the informed consent.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhongda Hospitallead
Study Sites (20)
Anhui Province Cancer Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangxi Medical University Affiliated Tumor Hospita
Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Jingmen NO.2People's Hospital
Jingmen, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central People's Hospital
Yichang, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shengyang, Liaoning, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Lishui Municipal Central Hospital
Lishui, Zhejiang, China
Related Publications (4)
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.
PMID: 16650261BACKGROUNDSun 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.
PMID: 33364949BACKGROUNDYu 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.
PMID: 33887111BACKGROUNDXue 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.
PMID: 36273202DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gao-Jun Teng, MD
Zhongda Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair, Center of IR and vascular surgery, Department of radiology
Study Record Dates
First Submitted
September 6, 2021
First Posted
October 11, 2021
Study Start
September 5, 2021
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
December 29, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share
Other researchers can contact the PI for data.