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临床试验/NCT05208619
NCT05208619招募中不适用

Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery

University Hospital, Bonn4 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2022年8月9日最近更新:
适应症

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

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

发起方
University Hospital, Bonn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Soehle

Vice Head of Department

University Hospital, Bonn

研究点 (4)

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