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临床试验/NCT06073795
NCT06073795尚未招募不适用

Ultrasound Guided Versus Fluoroscopy Guided Lumber Sympathetic Block in Chronic Lower Limb Ischemia

Assiut University0 个研究点目标入组 60 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
the total procedure time

研究概览

简要总结

The aim of this study is to compare total procedure time and success rate between FL-guided and US-assisted LSGBs in Lower Limb Ischemic patients.

详细描述

Morbidity and death in acute lower limb arterial occlusion are well described. The patients often are in a debilitated state, with multiple concurrent medical comorbidities. An association with hypercoagulable phenomena (e.g., active malignancy) may explain the frequency of some of these conditions. Other conditions, however, may be directly responsible for the occlusive event itself (e.g., the association of myocardial disease and peripheral embolization) (1, 2).

The sympathetic nervous system controls many of the involuntary functions of the human body and plays a role in chronic pain conditions such as complex regional pain syndrome (CRPS) (3).

About 20% of patients who suffered lower limb ischemic pain are not suitable for surgical intervention for various reasons. In these patients, a lumbar sympathetic ganglion block (LSGB) can be used to reduce pain, improve the walking status and activities of daily living, and may delay or avoid amputation. LSGB technique has become increasingly popular in recent decades, and several diseases are treated with LSGB, including neuropathic pain (NP), vascular pain, and erythematous extremity pain (4).

An LSGB refers to injecting drugs (local anesthetic drugs: lidocaine, ropivacaine, etc.) into the lumbar sympathetic ganglia of the corresponding segment to destroy the nerve conduction function, thereby achieving the method of treating certain diseases. The use of LSGB can destroy the innervation of sympathetic nerves on the blood vessels of the lower extremities, and the innervated blood vessels continue to expand to improve local blood circulation and nutrient supply, thereby reducing pain (5).

This block is typically performed in the prone position at the L3 level under fluoroscopic guidance. Fluoroscopy (FL)-guided LSGB has been a popular technique, as it provided great accuracy in confirming the location of needle tip or intravascular (IV) injection. However, this technique exposes patients to radiation and its success rate ranges from 67% with FL guidance to 83% with computed tomography (CT) guidance (6).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Lower Limb Ischemic patients need LSGB procedures

排除标准

  • • A body mass index (BMI) of >30 kg/m
  • A history of post-lumbar laminectomy with internal fixation or any severe anatomic variation, such as scoliosis and tumor.
  • History of lumbar sympathetic chemical or thermal neurolysis.
  • Pregnancy.
  • Infection at the puncture site.
  • Coagulopathy.
  • Allergy to local anesthetics.

结局指标

主要结局

the total procedure time

时间窗: two years

the time from the first radiographic image for the identification of the lumbar vertebral level to the completion of the bupivacaine injection (FL group), or the time from the US probe placement on the patient's skin to the completion of the bupivacaine injection (US group).

次要结局

  • success rate(two years)

研究者

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

Sally Ahmed kamel

assistant lecturer

Assiut University

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