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临床试验/NCT04212845
NCT04212845Unknown不适用

Erector Spinae Plane Block Versus Transforaminal Epidural Injection in Chronic Discogenic Low Back Pain

Ataturk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Visual analog pain score

研究概览

简要总结

Lumbar disc herniation is the main cause of low back pain and radicular leg pain. Steroids administered to the epidural area reduce the inflammatory response and pain by inhibiting the synthesis of proinflammatory agents. Epidural steroid injections are used in the treatment of lumbosacral radicular pain with various techniques including fluoroscopy-guided transforaminal and interlaminar injection.

Ultrasound-guided erector spina plan block (ESPB) was first described in 2016 and has been used for postoperative analgesia in many surgeries including thoracic and lumbar dermatomes. The distribution of local anesthesia in the ESPB from the paravertebral area to the transforaminal and epidural space has been shown in studies.

The aim of this study was to compare the efficacy of ultrasound-guided ESPB and fluoroscopic guided transforaminal epidural steroid injection in chronic discogenic low back pain.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologist's physiologic state I-III patients
  • Patients with unilateral radicular pain and low back pain persisting despite medical treatment.

排除标准

  • Spinal cord disease or spinal mechanical instability,
  • Previous low back surgery,
  • More than two levels of lumbar disc hernia,
  • Allergic to local anesthetic drugs to be used,
  • Use of oral anticoagulants,
  • Uncontrolled diabetes mellitus type I and II

研究组 & 干预措施

Group ESP

Active Comparator

Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine and 8 mg dexamethasone

干预措施: Bupivacaine;Dexamethasone Solution for Injection (Drug)

Group ESP

Active Comparator

Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine and 8 mg dexamethasone

干预措施: Ultrasound (Device)

Group TF

Active Comparator

Fluoroscopy-guided transforaminal injection with 4 ml of 0.25% bupivacaine and 8 mg dexamethasone

干预措施: Bupivacaine;Dexamethasone Solution for Injection (Drug)

Group TF

Active Comparator

Fluoroscopy-guided transforaminal injection with 4 ml of 0.25% bupivacaine and 8 mg dexamethasone

干预措施: Fluoroscopy (Device)

结局指标

主要结局

Visual analog pain score

时间窗: Post injection sixth month

Pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

次要结局

  • Oswestry Disability Index(Post injection first, third and sixth month)

研究者

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

Ahmet Murat Yayik

Assistant Professor

Ataturk University

研究点 (1)

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