Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 4
- 主要终点
- Opiate consumption
研究概览
简要总结
The aim of the study is to determine which regional anaesthesiological technique (thoracic epidural analgesia or paravertebral block) is more suitable for thoracic surgery
详细描述
Thoracic interventions (lung operations) are associated with considerable postoperative pain, whereby an open surgical procedure via a skin incision (thoracotomy) is more painful than a minimally invasive endoscopic intervention (thoracoscopy). In order to reduce pain, a regional anaesthetic is administered during the induction of anaesthesia, which reduces pain both intraoperatively and postoperatively. In thoracic surgery, thoracic epidural analgesia (PDA) and paravertebral block (PVB) are the main regional anaesthesiological measures used, although it is unclear which of the two procedures is superior in terms of efficiency and effectiveness. Particularly intraoperatively, but also to some extent postoperatively, regional anaesthesia alone is usually not sufficient for pain management. Rather, additional systemic (i.e. intravenous) analgesics (especially opioids) are administered. Therefore, the amount of these additionally administered analgesics is a measure of the efficiency of the regional anaesthesia procedure.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective thoracic surgery
- •American Society of Anaesthesiologists (ASA) 1-3 status
- •written informed consent
排除标准
- •pregnancy
- •adipositas (bmi > 30)
- •cardiac arrhythmia
- •coagulation abnormalities
- •chronic pain
- •opiate abuses
结局指标
主要结局
Opiate consumption
时间窗: intraoperative
intraoperative opiate consumption
次要结局
- postoperative pain(up to day 2 after surgery)
- anaesthetic depth(intraoperative)
- intraoperative nociception(intraoperative)
- Patient recovery(at day 1 after surgery)
- Patient satisfaction(at day 2 after surgery)
- pain score(from admission to post-anaesthesia care unit (PACU) until discharge from PACU (up to 1 hour after admission))
研究者
Martin Soehle
Vice Head of Department
University Hospital, Bonn
