Nalbuphine Versus Morphine for Perioperative Tumor Ablation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nalbuphine Allergy, Ablation, Safety

Intervention / Treatment
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* Drug: Nalbuphine
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tumor ablation using nalbuphine for pain control and anaesthesia<br>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<br>* Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation<br>* Other names: Tumor ablation using nalbuphine;|
| Active Comparator: Tumor ablation using morphine for pain control and anaesthesia<br>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<br>* Morphine hydrochloride injection is used for perioperative tumor ablation<br>* Other names: Tumor ablation using morphine;|

What is the study measuring?
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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 |