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临床试验/NCT05487326
NCT05487326招募中不适用

Comparison of Pain Relief Between High Thoracic Erector Spinae Plane Block and Cervical Epidural Injection

Keimyung University Dongsan Medical Center2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2022年8月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
82
试验地点
2
主要终点
Changes of numerical rating scale

研究概览

简要总结

The primary endpoint of this study was to identify whether there is a pain improving effect of high thoracic eretor spinae plane block (ESPB) when compared with cervical epidural injection

详细描述

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. However, these studies are limited by the small number of included patients.

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, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cervical spinal stenosis
  • cervical intervertebral disc herniation
  • cervical facet arthropathy
  • cervical foraminal stenosis

排除标准

  • Allergy to local anesthetics or contrast medium
  • Pregnancy
  • Spine deformity
  • Patients with coagulation abnormality

结局指标

主要结局

Changes of numerical rating scale

时间窗: baseline, 10 min after injection, 1wk after injection, 2 wks after injection, 4 wks after injection, 8 wks after injection

Changes of 11-point numerical rating scale (0-10)

次要结局

  • Changes of neck disability index(baseline, 8 wks after injection)

研究者

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

Ji Hee Hong

Professor

Keimyung University Dongsan Medical Center

研究点 (2)

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