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Nalbuphine Versus Morphine for Perioperative Tumor Ablation

Sponsor
Zhongda Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05073744
Collaborator
(none)
316
Enrollment
20
Locations
2
Arms
23.8
Anticipated Duration (Months)
15.8
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
316 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial
Actual Study Start Date :
Sep 5, 2021
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Analgesic efficiency [From the begin to 48 hours after procedure]

      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.

    Secondary Outcome Measures

    1. Pain intensity [From the begin to 48 hours after procedure]

      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.

    2. Analgesia satisfaction [Up to 4 hours]

      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.

    3. Duration of ablation [Up to 4 hours]

      Duration of the whole procedure

    4. Postoperative hospital stay [Up to 10 days]

      Days from the time of ablation to Discharge time

    5. Rate of continuous ablation without complaining of pain [Up to 4 hours]

      No. ablation without complaining of pain cases / No.Total cases * 100%

    6. Average daily dosage [From nalbuphine/morphine use to 48 hours after procedure]

      Total dose of nalbuphine or morphine / Total days of analgesia

    7. Health-related quality of life [7 days after procedure]

      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.

    Other Outcome Measures

    1. Safety end point [From nalbuphine/morphine use to 48 hours after procedure]

      Adverse reactions related with nalbuphine or morphine according to "Common Terminology Criteria for Adverse Events" by "National Cancer Institute" (NCI-CTCAE, version5.0)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Province Cancer Hospital Hefei Anhui China
    2 The Second Hospital of Anhui Medical University Hefei Anhui China
    3 The First Hospital of Lanzhou University Lanzhou Gansu China
    4 Guangxi Medical University Affiliated Tumor Hospita Nanning Guangxi China
    5 The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi China
    6 The Affiliated Cancer Hospital of Guizhou Medical University Guiyang Guizhou China
    7 Harbin Medical University Cancer Hospital Harbin Heilongjiang China
    8 Henan Provincial People's Hospital Zhengzhou Henan China
    9 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
    10 Jingmen NO.2People's Hospital Jingmen Hubei China
    11 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei China
    12 Yichang Central People's Hospital Yichang Hubei China
    13 The Second Xiangya Hospital of Central South University Changsha Hunan China
    14 Zhongda Hospital Southeast University Nanjing Jiangsu China 210009
    15 The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu China
    16 The First Bethune Hospital of Jilin University Changchun Jilin China
    17 Shengjing Hospital of China Medical University Shengyang Liaoning China
    18 Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai China
    19 Shanghai Tenth People's Hospital Shanghai Shanghai China
    20 Lishui Municipal Central Hospital Lishui Zhejiang China

    Sponsors and Collaborators

    • Zhongda Hospital

    Investigators

    • Principal Investigator: Gao-Jun Teng, MD, Zhongda Hospital Southeast University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gao-jun Teng, Chair, Center of IR and vascular surgery, Department of radiology, Zhongda Hospital
    ClinicalTrials.gov Identifier:
    NCT05073744
    Other Study ID Numbers:
    • NPRCT001
    First Posted:
    Oct 11, 2021
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Morphine
    Nalbuphine

    Study Results

    No Results Posted as of Oct 11, 2021