Postoperative Analgesic Effect of Hydromorphone on Chinese Patients Receiving Partial Pulmonary Resection Under Video-assisted Thoracoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Rest pain assessment at 8 a.m. at first day after surgery
研究概览
简要总结
Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump for patient controlled intravenous analgesic (PCIA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70≥ Age ≥18
- •Selective operation lung section with video-assisted thoracic surgery (VATS)
- •III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
- •Patients informed and agreed to join the study
排除标准
- •Abnormal function of liver and kidney
- •Allergic- dependence history of alcohol, opioids and Local anesthetics
- •No noncompliance
- •Mental disease history，language communication disorder，cicatricial diathesis
- •Underweight or overweight（BMI<18 or >30)
- •Patients not suitable for clinical subjects for other reasons
- •Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24 hours before the operation.
- •History of previous abnormal anaesthesia
- •Women during pregnancy or lactation
研究组 & 干预措施
Group M
Drug: Morphine Background: No Bolus infusion: 0.015 mg*kg-1
干预措施: Morphine (Drug)
Group NBH
Drug: Hydromorphone Background: No Bolus infusion: 0.002 mg*kg-1
干预措施: Hydromorphone (Drug)
Group BH
Drug: Hydromorphone Background: 0.002 mg*kg-1*h-1 Bolus infusion: 0.002 mg*kg-1
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Rest pain assessment at 8 a.m. at first day after surgery
时间窗: 8 a.m. at first day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 a.m. at first day after surgery
时间窗: 8 a.m. at first day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 a.m. at second day after surgery
时间窗: 8 a.m. at second day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 p.m. at third day after surgery
时间窗: 8 p.m. at third day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 0.5 hour after tracheal extubation
时间窗: 0.5 hour after tracheal extubation
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 p.m. at second day after surgery
时间窗: 8 p.m. at second day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 a.m. at third day after surgery
时间窗: 8 a.m. at third day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 p.m. surgery day
时间窗: 8 p.m. at surgery day
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 p.m. surgery day
时间窗: 8 p.m. at surgery day
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 a.m. at second day after surgery
时间窗: 8 a.m. at second day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 p.m. at second day after surgery
时间窗: 8 p.m. at second day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 p.m. at third day after surgery
时间窗: 8 p.m. at third day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 p.m. at first day after surgery
时间窗: 8 p.m. at first day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Activity pain assessment at 8 p.m. at first day after surgery
时间窗: 8 p.m. at first day after surgery
Visual Analogue Scale/Score to assess pain on coughing. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
Rest pain assessment at 8 a.m. at third day after surgery
时间窗: 8 a.m. at third day after surgery
Visual Analogue Scale/Score to assess pain at rest. VAS range from 0 to 100 millimeter. And 0 stands for no pain, while 100 stands for worst pain. Lower value is better.
次要结局
- Total Analgesia usage(8 p.m. at third day after surgery)
- Ratio of Nausea(8 p.m. at third day after surgery)
- Ratio of Vomiting(8 p.m. at third day after surgery)
- Total Antiemetic usage(8 p.m. at third day after surgery)