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临床试验/NCT06471907
NCT06471907招募中不适用

Comparison of Pain Relief and Peripheral Perfusion Index Using Different Volume of Erector Spinae Plane Block

Keimyung University Dongsan Medical Center2 个研究点 分布在 2 个国家目标入组 64 人开始时间: 2024年6月13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
64
试验地点
2
主要终点
Numerical rating scale changes among 5 times period

研究概览

简要总结

The primary endpoint of this study is to compare the pain relief and peripheral perfusion index using different volume of local anesthetics in erector spinae plane block.

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. Perfusion index is an indirect method which can present the degree of peripheral perfusion. Moreover, it is known as a more sensitive measurement tool than the rise of skin temperature. The apply of perfusion index is very simple and noninvasive. The degree of PI increase has been used to determine the success of peripheral nerve block. The volume of local anesthetics has been used 10-30 ml. However, most effective dosage with proper pain relief has never been suggested.

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

  • lumbar disc herniation
  • lumbar foraminal stenosis
  • lumbar central stenosis
  • lumbar spondylolisthesis
  • numerical rating scale > 4
  • back pain functional scale < 45
  • duration of pain > 1 mon
  • patients who can fully understand all items described in back pain functional scale

排除标准

  • Allergy to local anesthetics or contrast medium
  • Pregnancy
  • Spine deformity
  • Prior history of lumbar spine surgery
  • No previous lumbar MRI or CT
  • Patients with coagulation abnormality

结局指标

主要结局

Numerical rating scale changes among 5 times period

时间窗: Baseline, 2 weeks, 4 weeks, 8 weeks after the completion of erector spine plane block

minimum (1) and maximum value (10), lower score means better outcome

次要结局

  • Perfusion index changes among 4 times period(baseline, 10minutes after ESPB, 20 minutes after ESPB, 30 minutes after ESPB)
  • back pain functional scale among 3 times period(Baseline, 4 weeks, 8 weeks after the completion of erector spine plane block)

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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