Impact of Dexamethasone on the Post Operative Inflammatory Response and on the Occurrence of Post Thoracotomy Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- cytokine elevation
研究概览
简要总结
Post thoracotomy pain syndrome still affects 50% of patients after a thoracic surgery. Pathogenesis is unclear but there is growing evidence that neuro inflammation may play a significant role. Dexamethasone is a very potent anti-inflammatory drug. The hypothesis of this study is that dexamethasone, given pre operatively, would help reduce the incidence of post thoracotomy pain syndrome 3 months after surgery, by reducing the inflammatory response, in patients undergoing elective thoracic surgery that includes thoracic epidural analgesia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective thoracic surgery using a thoracotomy incision and thoracic epidural analgesia
- •ASA I-III
- •age 18-75 yo
排除标准
- •contra-indication to thoracic epidural analgesia
- •patient refusal
- •patients already taking cortisone or dexamethasone
- •patients on chronic opioid medication
研究组 & 干预措施
dexamethasone 10 mg
Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously
干预措施: Dexamethasone (Drug)
normal saline
Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision
干预措施: Normal Saline (Drug)
结局指标
主要结局
cytokine elevation
时间窗: 24 h after surgery
次要结局
- incidence of post thoracotomy pain syndrome(6 months after surgery)
- incisional and shoulder pain(acute post operative period)
- Brief pain inventory questionnaire(6 months after surgery)
- Leeds Assessment of Neuropathic Signs and Symptoms questionnaire(three and six months after surgery)
- cytokine elevation(48 h after surgery)
研究者
Veronique Brulotte
M.D., M.Sc.
Maisonneuve-Rosemont Hospital