Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled ：A Randomized, Parallel Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 主要终点
- Analgesic efficiency
研究概览
简要总结
This randomized, parallel controlled, single blind trial is designed to evaluate the efficacy and safety of hydromorphone versus morphine for perioperative analgesia in lung tumor ablation.
详细描述
Although the consensus of relevant guidelines and clinical studies recommend the use of opioids for perioperative analgesia in pulmonary tumor ablation surgery, there is a lack of specific analgesic programs for clinical reference. In view of the advantages of clinical application of hydromorphone and the lack of evidence for its application in perioperative analgesia of pulmonary tumor ablation, this study aims to explore the efficacy and safety of hydromorphone in perioperative analgesia of pulmonary tumor ablation, and provide some reference and suggestions for perioperative analgesia of pulmonary tumor ablation.
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
- Double (Participant, Care Provider)
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
- •Voluntarily attend and sign the informed consent form in person;
- •Patients undergoing selective pulmonary tumor ablation;
- •The Eastern Collaborative Oncology Group (ECOG) defines an activity status score of 2 or less;
- •The estimated survival time is more than 3 months;
- •Age 18-80, both sexes.
排除标准
- •Severe coagulation dysfunction that cannot be corrected;
- •History of severe cardio-cerebrovascular and respiratory diseases;
- •Patients allergic to test drugs or contrast media;
- •Patients with opioid addiction;
- •Patients with cognitive dysfunction;
- •Participated in other clinical investigators within three months;
- •Investigators or their family members directly involved in the trial;
- •Those who are deemed unfit to participate in the study by the investigator.
研究组 & 干预措施
Experimental: Lung tumor ablation using hydromorphone for pain control and anaesthesia
Premedication:hydromorphone is started 15min before surgery with a single subcutaneous injection of 2mg.
Intraoperative administration:NRS（Numeric Rating Scale）≥7 during operation, 2mg hydromorphone is injected intravenously and slowly pushed for 2-3 minutes.
Postoperative administration:The drug is administered as needed according to the patient's postoperative pain, 2mg/time.
干预措施: Hydromorphone Hydrochloride (Drug)
Active Comparator:Lung tumor ablation using morphine for pain control and anaesthesia
Premedication:morphine is started 15min before surgery with a single subcutaneous injection of 10mg.
Intraoperative administration:NRS（Numeric Rating Scale）≥7 during operation, 10mg morphine is injected intravenously and slowly pushed for 2-3 minutes.
Postoperative administration:The drug is administered as needed according to the patient's postoperative pain, 10mg/time.
干预措施: Morphine hydrochloride (Drug)
结局指标
主要结局
Analgesic efficiency
时间窗: The analgesia is evaluated at 1 hour before surgery, 5 minutes after the beginning of ablation
effective cases / total cases \* 100%. The NRS（Numeric Rating Scale） score ≤3 at all evaluation time points is considered as effective analgesia.
次要结局
- Incidence of adverse reactions(perioperative period)