Evaluation of an "Opioid Free Anesthesia" Protocol in Thoracoscopic Carcinological Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
Evaluation of a service OFA (Opioid-free Anesthesia) protocol on post-operative pain of patients operated on by video-thoracoscopic carcinologic surgery by counting them to a group of patients receiving standard general anesthesia with opioid.
详细描述
A service protocol based on opioid-free anesthesia in patients undergoing pulmonary carcinologic surgery under video-thoracoscopy will be evaluated.
The investigative team want to recruit 100 patients prospectively. These patients will be randomly assigned on the day of surgery between OFA (Opioid Free Anesthesia) and OBA (Opioid Based Anesthesia).
Anesthesia and analgesia of patients in the OFA group will be performed without morphine according to the validated local protocol. We will use level 1 and 2 analgesics (paracetamol, NSAIDs and nefopam) associated with an erector spine block and anesthesia under propofol, dexmedetomidine and ketamine ivse.
Patients in the OBA group will have so-called "basic" anesthesia and analgesia with opioids according to usual practice.
Postoperative pain by collecting morphine consumption in the first 48 hours postoperatively between the two groups will be compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •Patient operated on pulmonary carcinologic surgery by thoracoscopy of a foreseeable duration greater than 2 hours
排除标准
- •Patient with unstable unstable unstable coronary artery disease,
- •Patient contraindicated for the use of dexmedetomidine: heart rate<50 / min, High degree atrioventricular block (2 and 3) unless fitted (carrier of a pacemaker),
- •Patient on beta-blocker, allergy to Dexdor®,
- •Patient allergic to other drugs used in OFA (Paracetamol and NSAIDs).
- •Renal insufficiency patient with creatinine clearance<30ml/min will not be excluded but will not receive NSAIDs.
- •Minor patient,
- •Adult patient under guardianship or curators.
结局指标
主要结局
Morphine consumption
时间窗: Day 2
Total morphine consumption over the first 48 post operative hours in milligrammes
次要结局
- Preoperatory haemodynamic tolerance(Day 0)
- Long-term morphine consumption(Month-3)
- Physical form recovery(Month-3)
- Quality of intraoperative anesthesia(Day 0)
- Chronic neuropathic pain(Month-3)
- Ileus Postoperative(Day 4)
- Duration of hospitalization(Day 10)