Analgesic Efficacy and Safety of Nalbuphine Versus Morphine for Perioperative Tumor Ablation: a Randomized, Control, Multicentre Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 316
- 试验地点
- 20
- 主要终点
- Analgesic efficiency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring tumor ablation;
- •Voluntarily participate and sign the informed consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Nalbuphine (Drug)
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.
干预措施: Morphine (Drug)
结局指标
主要结局
Analgesic efficiency
时间窗: 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.
次要结局
- Pain intensity(From the begin to 48 hours after procedure)
- Analgesia satisfaction(Up to 4 hours)
- Duration of ablation(Up to 4 hours)
- Rate of continuous ablation without complaining of pain(Up to 4 hours)
- Postoperative hospital stay(Up to 10 days)
- Average daily dosage(From nalbuphine/morphine use to 48 hours after procedure)
- Health-related quality of life(7 days after procedure)
研究者
Gao-jun Teng
Chair, Center of IR and vascular surgery, Department of radiology
Zhongda Hospital