ERECTOR SPINAE PLANE BLOCK COMBINED WITH GENERAL ANAESTHESIA VERSUS CONVENTIONAL GENERAL ANAESTHESIA IN LUMBAR SPINE SURGERY
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Anaesthetic requirements:
研究概览
简要总结
Ultrasound guided erector spinae plain block combined with general anaesthesia versus conventional general anaesthesia in lumbar spine surgery, it's hypothesized that combined regional anaesthesia with general anaesthesia in lumbar spine surgery may reduce the anaesthetic requirements, aid in controlled hypotension and improve the perioperative pain management.
详细描述
Primary outcomes:
• Anaesthetic requirements: based on entropy monitoring(state and response entropy monitoring and the difference as a measure for adequacy of analgesia) and haemodynamic parameters ( heart rate and mean arterial blood pressure) at the following time intervals: before induction, after induction, after giving either ESP block or multimodal analgesia and starting surgical stimulus, at 30 min intervals, at end of anaesthesia, at eye opening.
Secondary outcomes:
- Stress response measurement based on serum cortisol and blood glucose levels
- Controlled hypotensive anaesthesia: various drugs required and doses given
- Intraoperative and postoperative analgesia.
- Postanaesthesia care unit data concerning recovery.
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 (Participant, Investigator)
盲法说明
closed envelope method
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing lumbar spine surgery
排除标准
- •Coagulation disorders.
- •BMI > 30 or < 18.
- •Patients with surgical site infection.
- •Patients with unstable spine integrity like fractures or scoliosis.
- •Hypertensive ,cardiac and diabetic patients.
研究组 & 干预措施
ultrasound guided erector spinae block and general anaesthesia
Ultrasound guided erector spine plane block is done after general anaesthesia and prone positioning
干预措施: Erector spinae plane block (Procedure)
Multimodal analgesia with general anaesthesia
Multimodal analgesia given with general anaesthesia in form of ketorolac and paracetamol
干预措施: Multimodal analgesia (Drug)
结局指标
主要结局
Anaesthetic requirements:
时间窗: the surgery period
based on entropy monitoring and haemodynamic parameters.
次要结局
未报告次要终点
研究者
Mohamed Elsayed
doctor
University of Alexandria