Clinical trial NCT05073744: Nalbuphine Versus Morphine for Perioperative Tumor Ablation
Official title: Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nalbuphine Allergy
Ablation
Safety
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients requiring tumor ablation;
* Voluntarily participate and sign the informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Analgesic efficiency
timeFrame: From the begin to 48 hours after procedure
Secondary outcomes:
measure: Pain intensity
timeFrame: From the begin to 48 hours after procedure
measure: Analgesia satisfaction
timeFrame: Up to 4 hours
measure: Duration of ablation
timeFrame: Up to 4 hours
measure: Postoperative hospital stay
timeFrame: Up to 10 days
measure: Rate of continuous ablation without complaining of pain
timeFrame: Up to 4 hours
measure: Average daily dosage
timeFrame: From nalbuphine/morphine use to 48 hours after procedure
measure: Health-related quality of life
timeFrame: 7 days after procedure
Other outcomes:
measure: Safety end point
timeFrame: From nalbuphine/morphine use to 48 hours after procedure
Locations:
city: Hefei
country: China
facility: Anhui Province Cancer Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospita
state: Guangxi
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Guiyang
country: China
facility: The Affiliated Cancer Hospital of Guizhou Medical University
state: Guizhou
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Jingmen
country: China
facility: Jingmen NO.2People's Hospital
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Yichang
country: China
facility: Yichang Central People's Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Shengyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Lishui
country: China
facility: Lishui Municipal Central Hospital
state: Zhejiang
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sun 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.
citation: Yu 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.
citation: Xue 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.