Comparison Between Ultrasound Guided Erector Spinae Block vs Thoracolumbar Interfascial Plane Block in Lumbar Spine Surgeries;Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Total postoperative fentanyl requirements
研究概览
简要总结
Aim of this Study will be to compare Ultrasound guided erector spinae block vs thoracolumbar interfascial plane (TLIP) block in lumbar spine surgeries.
详细描述
A total of 180 patients who will be scheduled for single-level lumbar discectomy and laminectomy surgery under general anesthesia will be included in this trial between October 2022 to March 2023.
Inclusion criteria:
The participants will be aged between 20 and 65 years, and will be classified per the American Society of Anesthesiologists (ASA) classification as ASA I-II.
The exclusion criteria Will be a history of coagulation abnormality, anticoagulant treatment, allergies to local anesthetics, skin infections at the site of block area, pregnancy or lactation, and refusal to participate in the study.
A computer program will be used to randomize the participants into 3 groups. Each group (mTLIP block, ESPB, and control) will compose of 60 patients. All patients will be monitored with the standard ASA criteria, electrocardiography, noninvasive blood pressure, and pulse oximetry. Midazolam (2 mg) will be administered intravenously (IV) for sedation. Anesthesia induction will be performed with IV propofol (2-2.5 mg/kg), fentanyl (1-1.5 mg/kg), and rocuronium bromide (0.9 mg/ kg). The patients will be placed in the prone position following intubation. Sevoflurane will be used in a mixture of oxygen and fresh air for anesthesia maintenance. Fentanil will be administered for intraoperative analgesia according to the baseline heart rate and mean arterial pressure of the patients. The intraoperative data (heart rate, peripheral oxygen saturation, noninvasive arterial pressure, and end-tidal carbon dioxide level) will be recorded at 5-minute intervals during the operation. All patients will do lumbar spine surgery by the same surgical team using the same technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing lumbar spine surgery
- •American Society of Anesthesiologists (ASA) classification as ASA I-II.
排除标准
- •coagulation abnormality
- •anticoagulant treatment,
- •allergies to local anesthetics,
- •skin infections at the site of block area,
- •pregnancy or lactation,
- •refusal to participate in the study.
研究组 & 干预措施
control group
Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block
干预措施: Propofol (Drug)
control group
Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block
干预措施: Fentanyl (Drug)
control group
Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block
干预措施: Rocuronium (Drug)
control group
Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block
干预措施: Sevoflurane (Drug)
Erector spinae plane block
Patients will recieve ultrasound guided erector spinae plane block.
干预措施: Propofol (Drug)
Erector spinae plane block
Patients will recieve ultrasound guided erector spinae plane block.
干预措施: Fentanyl (Drug)
Erector spinae plane block
Patients will recieve ultrasound guided erector spinae plane block.
干预措施: Rocuronium (Drug)
Erector spinae plane block
Patients will recieve ultrasound guided erector spinae plane block.
干预措施: Sevoflurane (Drug)
Erector spinae plane block
Patients will recieve ultrasound guided erector spinae plane block.
干预措施: Erector spinae plane block (Other)
Thoracolumbar interfascial plane block
Patients will recieve ultrasound guided thoracolumbar interfascial plane block.
干预措施: Propofol (Drug)
Thoracolumbar interfascial plane block
Patients will recieve ultrasound guided thoracolumbar interfascial plane block.
干预措施: Fentanyl (Drug)
Thoracolumbar interfascial plane block
Patients will recieve ultrasound guided thoracolumbar interfascial plane block.
干预措施: Rocuronium (Drug)
Thoracolumbar interfascial plane block
Patients will recieve ultrasound guided thoracolumbar interfascial plane block.
干预措施: Sevoflurane (Drug)
Thoracolumbar interfascial plane block
Patients will recieve ultrasound guided thoracolumbar interfascial plane block.
干预措施: Thoracolumbar interfascial plane block (Other)
结局指标
主要结局
Total postoperative fentanyl requirements
时间窗: 24 hours
Total postoperative fentanyl requirements
次要结局
- pain score at rest and during movement(24 hours)
- time of first postoperative analgesic request(24 hours)
- opioids side effects(24 hours)
研究者
Mona Mohamed Mogahed
Associate professor
Tanta University
