The Effect of Adjuvant Epidural Magnesium Sulfate to Bupivacaine and Morphine on Post-thoracotomy Pain Control: A Randomized Double Blind Clinical Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- severity of post-thoracotomy pain
研究概览
简要总结
Pain after thoracotomy is very severe and may cause pulmonary complications. Thoracic epidural analgesia has greatly decreased the pain experience and its consequences. However, new ways of decreasing post-operative opioid drugs consumption is an important issue of research. We aim to evaluate the effect of adding epidural magnesium sulfate to bupivacaine and morphine on pain control and the amount of opioid consumption after thoracotomy. Eighty patients undergoing thoracotomy at a tertiary cardiothoracic referral center will be enrolled in a randomized double blind trial. Patients randomly will be allocated in two groups. Bupivacaine (12.5 mg) plus morphine (2 mg) will be administered epidurally for all patients at the end of operation. Patients in group I will be received epidural magnesium sulfate (50 mg) and patients in Group II will be received normal saline as an adjuvant. Visual analog scale (VAS) score and the amount of morphine consumption will be measured during 24 hours post-operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 85 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical statuses I-III
- •Undergoing thoracotomy
排除标准
- •Known hypersensitivity to magnesium sulfate
- •Renal failure
- •Hepatic dysfunction
- •Severe obesity
- •Psychotic or neurologic diseases
- •Currently taking opioid or calcium channel blocker
- •AV block degree II or III
- •Refused to participate in trial
研究组 & 干预措施
Group I
magnesium group (Mg)
干预措施: magnesium sulfate (Drug)
Group II
control group (C)
干预措施: normal saline (Drug)
结局指标
主要结局
severity of post-thoracotomy pain
时间窗: 24 hours after thoracotomy
VAS (visual analog scale: 0-10 cm (0 cm = no pain and 10 cm = the worst pain)) score will be measured
次要结局
未报告次要终点
研究者
Shadi Baniasadi
Dr
National Research Institute of Tuberculosis and Lung Disease, Iran
