Nalbuphine Versus Morphine for Perioperative Tumor Ablation

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.

Study Overview

• Status: Recruiting
• Conditions: Safety; Ablation; Nalbuphine Allergy
• Intervention / Treatment: Drug: Nalbuphine; Drug: Morphine

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 Type: Interventional
• Enrollment (Anticipated): 316
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hai-Dong Zhu, MD; Phone Number: 86-25-83262224; Email: zhuhaidong9509@163.com
• Study Contact Backup: Name: Xiao-Yan Wang; Phone Number: 86 13851821464; Email: xywangseu@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • Anhui Province Cancer Hospital
    • Hefei, Anhui, China
      • Not yet recruiting
      • The second hospital of Anhui medical university
  • Gansu
    • Lanzhou, Gansu, China
      • Not yet recruiting
      • The First Hospital of Lanzhou University
  • Guangxi
    • Nanning, Guangxi, China
      • Not yet recruiting
      • The People's Hospital of Guangxi Zhuang Autonomous Region
    • Nanning, Guangxi, China
      • Not yet recruiting
      • Guangxi Medical University Affiliated Tumor Hospita
  • Guizhou
    • Guiyang, Guizhou, China
      • Not yet recruiting
      • The Affiliated Cancer Hospital of Guizhou Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Not yet recruiting
      • Harbin medical university cancer hospital
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Provincial People's Hospital
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • The first affiliated hospital of Zhengzhou university
  • Hubei
    • Jingmen, Hubei, China
      • Not yet recruiting
      • Jingmen NO.2People's Hospital
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Yichang, Hubei, China
      • Not yet recruiting
      • Yichang Central People's Hospital
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • The second Xiangya hospital of central south university
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
    • Xuzhou, Jiangsu, China
      • Not yet recruiting
      • The Affiliated Hospital of Xuzhou Medical University
  • Jilin
    • Changchun, Jilin, China
      • Not yet recruiting
      • The First Bethune Hospital of Jilin University
  • Liaoning
    • Shengyang, Liaoning, China
      • Not yet recruiting
      • Shengjing Hospital Of China Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Shanghai Tenth People's Hospital
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  • Zhejiang
    • Lishui, Zhejiang, China
      • Not yet recruiting
      • Lishui Municipal Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tumor ablation using nalbuphine for pain control and anaesthesia; 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.	Drug: Nalbuphine; Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation; Other Names: Tumor ablation using nalbuphine
Active Comparator: Tumor ablation using morphine for pain control and anaesthesia; 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.	Drug: Morphine; Morphine hydrochloride injection is used for perioperative tumor ablation; Other Names: Tumor ablation using morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Duration of ablation	Duration of the whole procedure	Up to 4 hours
Postoperative hospital stay	Days from the time of ablation to Discharge time	Up to 10 days
Rate of continuous ablation without complaining of pain	No. ablation without complaining of pain cases / No.Total cases * 100%	Up to 4 hours
Average daily dosage	Total dose of nalbuphine or morphine / Total days of analgesia	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.	7 days after procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhongda Hospital
• Investigators: Principal Investigator: Gao-Jun Teng, MD, Zhongda Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2021
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Estimate): December 29, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Nalbuphine
• Other Study ID Numbers: NPRCT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Other researchers can contact the PI for data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No