Nalbuphine Versus Morphine for Perioperative Tumor Ablation
- Conditions
- Nalbuphine AllergyAblationSafety
- Interventions
- Registration Number
- NCT05073744
- Lead Sponsor
- Zhongda Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 316
- Patients requiring tumor ablation;
- Voluntarily participate and sign the informed consent.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tumor ablation using nalbuphine for pain control and anaesthesia Nalbuphine 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. Tumor ablation using morphine for pain control and anaesthesia Morphine 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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.
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.
Duration of ablation Up to 4 hours Duration of the whole procedure
Rate of continuous ablation without complaining of pain Up to 4 hours No. ablation without complaining of pain cases / No.Total cases \* 100%
Postoperative hospital stay Up to 10 days Days from the time of ablation to Discharge time
Average daily dosage From nalbuphine/morphine use to 48 hours after procedure Total dose of nalbuphine or morphine / Total days of analgesia
Trial Locations
- Locations (20)
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Anhui Province Cancer Hospital
🇨🇳Hefei, Anhui, China
Guangxi Medical University Affiliated Tumor Hospita
🇨🇳Nanning, Guangxi, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
The People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The Affiliated Cancer Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Jingmen NO.2People's Hospital
🇨🇳Jingmen, Hubei, China
Yichang Central People's Hospital
🇨🇳Yichang, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
Shengjing Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
Lishui Municipal Central Hospital
🇨🇳Lishui, Zhejiang, China