Comparing the General Anesthesia, the General Anesthesia With the ESP Block or TLIP Block in the Patients Undergoing Lumbar Surgeries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- A Visual Analogue Scale (numerical rating scale (NRS)
研究概览
简要总结
The regional methods of anesthesia for the neurosurgical operations of the spine and spinal cord reducing the needs for opioids intra operatively and reducing pain in the postoperative period, decrease the numbers of failed back syndrome.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •back surgery
排除标准
- •contraindications to the regional method of analgesia,
- •patient refusal,
- •patients with diabetes mellitus
- •mental illness
- •pregnancy
研究组 & 干预措施
General anesthesia
induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg maintenance anesthesia: sevoflurane, doses of the inhalation agent according to bispectral index (BIS) monitor ( target BIS level 40-60) and fentanyl 1-5 mcg\kg\h.
干预措施: regional anesthesia (Procedure)
Combined anesthesia: general anesthesia and Erector spinae plane block (ESP block)
induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg ESP- block with US control with single shot of local anesthetic ( bupivacaine 0.375% or 0.25% 20-30 ml) is performed after induction.
maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\kg\h.
干预措施: regional anesthesia (Procedure)
Combined anesthesia: General anesthesia and Thoraco-lumbar interfacial plane block (TLIP block)
induction: propofol 1.5-2.5 mg\kg IV bolus and fentanyl 1-2 mcg\kg TLIP- block with US control with single shot of local anesthetic ( bupivacaine 0.25% 15 ml or mixed bupivacaine 0.25% 7.5 ml and lidocaine 2% 7.5 ml) is performed after induction.
maintenance anesthesia: sevoflurane, doses of the inhalation agent according to BIS monitor ( target BIS level 40-60) and fentanyl 0.5-1.5 mcg\kg\h.
干预措施: regional anesthesia (Procedure)
结局指标
主要结局
A Visual Analogue Scale (numerical rating scale (NRS)
时间窗: 48 hour after surgery
minimum 0 ( no pain), maximum 10 (the worst pain ever)
次要结局
- A Visual Analogue Scale (numerical rating scale (NRS)(3 month after surgery)
研究者
Plechysta Yelyzaveta
Chief of the anesthesia department
Anesthesia Research Group UA