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临床试验/NCT05596227
NCT05596227已完成不适用

Comparison Between Ultrasound Guided Erector Spinae Block vs Thoracolumbar Interfascial Plane Block in Lumbar Spine Surgeries;Randomized Controlled Trial

Tanta University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2022年10月20日最近更新:
适应症
干预措施

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

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

Placebo Comparator

Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block

干预措施: Propofol (Drug)

control group

Placebo Comparator

Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block

干预措施: Fentanyl (Drug)

control group

Placebo Comparator

Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block

干预措施: Rocuronium (Drug)

control group

Placebo Comparator

Patients will not recieve either erector spinae plane block nor thoracolumbar interfascial plane block

干预措施: Sevoflurane (Drug)

Erector spinae plane block

Active Comparator

Patients will recieve ultrasound guided erector spinae plane block.

干预措施: Propofol (Drug)

Erector spinae plane block

Active Comparator

Patients will recieve ultrasound guided erector spinae plane block.

干预措施: Fentanyl (Drug)

Erector spinae plane block

Active Comparator

Patients will recieve ultrasound guided erector spinae plane block.

干预措施: Rocuronium (Drug)

Erector spinae plane block

Active Comparator

Patients will recieve ultrasound guided erector spinae plane block.

干预措施: Sevoflurane (Drug)

Erector spinae plane block

Active Comparator

Patients will recieve ultrasound guided erector spinae plane block.

干预措施: Erector spinae plane block (Other)

Thoracolumbar interfascial plane block

Active Comparator

Patients will recieve ultrasound guided thoracolumbar interfascial plane block.

干预措施: Propofol (Drug)

Thoracolumbar interfascial plane block

Active Comparator

Patients will recieve ultrasound guided thoracolumbar interfascial plane block.

干预措施: Fentanyl (Drug)

Thoracolumbar interfascial plane block

Active Comparator

Patients will recieve ultrasound guided thoracolumbar interfascial plane block.

干预措施: Rocuronium (Drug)

Thoracolumbar interfascial plane block

Active Comparator

Patients will recieve ultrasound guided thoracolumbar interfascial plane block.

干预措施: Sevoflurane (Drug)

Thoracolumbar interfascial plane block

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mona Mohamed Mogahed

Associate professor

Tanta University

研究点 (1)

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