Nalbuphine Versus Morphine for Perioperative Tumor Ablation

Safety Clinical Trial

Official title:

Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073744
• Other study ID #: NPRCT001
• Status: Recruiting
• Phase: Phase 4
• Start date: September 5, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2022
• Source: Zhongda Hospital
• Contact: Xiao-Yan Wang
• Phone: 86 13851821464
• Email: xywangseu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 316
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ablation
• Safety

Intervention

Drug:
• Nalbuphine
Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation
• Morphine
Morphine hydrochloride injection is used for perioperative tumor ablation

Locations

Country	Name	City	State
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Affiliated Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Province Cancer Hospital	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Jingmen NO.2People's Hospital	Jingmen	Hubei
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Lishui Municipal Central Hospital	Lishui	Zhejiang
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospita	Nanning	Guangxi
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shengyang	Liaoning
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yichang Central People's Hospital	Yichang	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety end point	Adverse reactions related with nalbuphine or morphine according to "Common Terminology Criteria for Adverse Events" by "National Cancer Institute" (NCI-CTCAE, version5.0)	From nalbuphine/morphine use to 48 hours after procedure
Primary	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	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.	From the begin to 48 hours after procedure
Secondary	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.	Up to 4 hours
Secondary	Duration of ablation	Duration of the whole procedure	Up to 4 hours
Secondary	Postoperative hospital stay	Days from the time of ablation to Discharge time	Up to 10 days
Secondary	Rate of continuous ablation without complaining of pain	No. ablation without complaining of pain cases / No.Total cases * 100%	Up to 4 hours
Secondary	Average daily dosage	Total dose of nalbuphine or morphine / Total days of analgesia	From nalbuphine/morphine use to 48 hours after procedure
Secondary	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.	7 days after procedure