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临床试验/NCT06963424
NCT06963424已完成不适用

Pain Relief and Peripheral Perfusion Index When Local Anesthetics Injected in Different Final Target Area During Lumbar Erector Spinae Block

Keimyung University Dongsan Medical Center1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年5月13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
90
试验地点
1
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 when local anesthetics injected in different final target area during lumbar erector spinae block The secondary endpoint of this study is to compare the procedure related pain

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. The final target area of ESPB of cervical, thoarcic, and lumbar regiona is transverse process. Once the needle contact the tip of the transverse process, local anesthetics is injected subsequentely. However, contacting the bony structure with the needle can generage procedure related pain. If ESPB can be performed without touching the transverse process, the satisfaction of patient would be increased. Actually, intertransverse ligament, which is visibe by ultrasound, is present between transverse process. Therefore, if local anesthetics is injected after targeting intertransverse ligament, same effect of pain relief with tarting of transverse process of ESPB is uncertain

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
否

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

研究组 & 干预措施

transverse process group

Placebo Comparator

lumbar ESPB was performed with final target at transverse process

干预措施: Erector Spinae Plane Block (Procedure)

intertransverse ligagment group

Experimental

lumbar ESPB was performed with final target at intertransverse ligament

干预措施: Erector Spinae Plane Block (Procedure)

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 treatment outcome

次要结局

  • 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 (1)

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