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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05073744
Other study ID # NPRCT001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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