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临床试验/NCT05114200
NCT05114200已完成不适用

Evaluation of Drug Spread in Ultrasound-Guided Erector Spina Plane Block With Fluoroscopy

Istanbul University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
The level of contrast spread in the anteroposterior plane

研究概览

简要总结

The purpose of this study is to evaluate the injectate spread in erector spinae plane blocks under fluoroscopy.

详细描述

The study will be carried out between March 2021 and June 2021 in Istanbul University Istanbul Medical Faculty Pain Medicine Clinic. Patients who undergone erector spinae plane block for any indication over the age of 18 will be included in the study.

All procedures will be performed in the operating room under standard monitorization (ECG, pulse oximetry, non-invasive blood pressure) and all patients will be in the prone position. The application area will be sterilized with povidone-iodine solution. Mild sedation will be achieved by using 1-2 mg of midazolam and 50-75 µg of fentanyl iv. The target area will be visualized by General Electrics (GE) Logiq e Ultrasound device using a 10-12 MHz linear probe or 1-4 MHz curvilinear probe. Transverse processes and erector spina muscles will be visualised at the target vertebral level. After local anesthesia (1-2 cc 2% lidocaine), a 20 gauge spinal needle will be inserted using the "in-plane technique". The needle will be advanced to the transverse process, after it's position is confirmed with hydrodissection, a solution of 40 mg triamcinolone, 10 ml 0,5% bupivacaine, 10 ml radiopaque contrast agent will be injected. Contrast spread will be evaluated with the fluoroscopy in the anterior-posterior and lateral positions immediately and 30 minutes after the procedure. The level of contrast radiating in the AP plane and passing through the paravertebral space and the epidural distance in the lateral plane will be noted. In addition, sensory examination with a pin prick test will be performed to determine the presence of dermatomal hypoalgesia and/or analgesia.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18 years old
  • Patients who underwent erector spinae plane block for any reasons

排除标准

  • Age under the age of 18
  • Patients without a clear contrast spread under fluoroscopy

结局指标

主要结局

The level of contrast spread in the anteroposterior plane

时间窗: 30 minutes

Fluoroscopic images will be taken in the anteroposterior plane, number of vertebral levels the injectate has spread out will be recorded.

次要结局

  • Contrast spread to epidural area(30 minutes)
  • Contrast spread to paravertebral space(30 minutes)
  • Pinprick test(30 minutes)

研究者

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

Halil Cetingok

Assistant Professor

Istanbul University

研究点 (1)

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