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临床试验/NCT03343548
NCT03343548已完成不适用

The Effect of Adjuvant Epidural Magnesium Sulfate to Bupivacaine and Morphine on Post-thoracotomy Pain Control: A Randomized Double Blind Clinical Trial Study

National Research Institute of Tuberculosis and Lung Disease, Iran1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

magnesium group (Mg)

干预措施: magnesium sulfate (Drug)

Group II

Placebo Comparator

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

发起方
National Research Institute of Tuberculosis and Lung Disease, Iran
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Shadi Baniasadi

Dr

National Research Institute of Tuberculosis and Lung Disease, Iran

研究点 (1)

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