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临床试验/NCT01954888
NCT01954888终止不适用

Impact of the Ultrasound-guided Approach on the Efficiency and Safety of the Stellate Ganglion Block in Chronic Pain

Maisonneuve-Rosemont Hospital2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature

研究概览

简要总结

The first purpose of this study is to compare the effectiveness of the stellate ganglion block realized with two different approaches (blind and ultrasound-guided) in patients with a diagnosis of complex regional pain syndrome.

The second purpose of this study is to determine the safest approach and to compare the safety profiles of the two approaches.

详细描述

To evaluate whether the ultrasound guided approach is more effective than the blind technique in producing a greater than 1.5 degree Celsius rise in ipsilateral arm temperature after a stellate ganglion block.

Blocks will both be performed with 10 mL of xylocaine/bupivacaine. Secondary outcomes will be the impact of the approach (blind vs ultrasound) on pain reduction, horner syndrome, side effects (hoarseness, dysphagia, pharyngeal discomfort) and complications (blood aspiration, intravascular injection).

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients aged 18 to 80 years
  • Patients with a new or known diagnosis of complex regional pain syndrome (according to the criteria of Budapest) at the upper extremity

排除标准

  • Refusal of a patient
  • Coagulopathy
  • Systemic infection or local infection at the needle injection site
  • Major deformation at the level of the neck (radiotherapy, surgery, etc. )
  • Concomitant chronic pain syndrome
  • Post-pneumonectomy on the controlateral side
  • Severe hepatic impairment or severe renal impairment (Clcr under 30 ml/min)
  • Known allergy to local anesthetics of amide type
  • Inability to understand a numeric pain scale

结局指标

主要结局

proportion of patients reaching >1.5 °C rise in ipsilateral arm temperature

时间窗: thirty minutes after block

次要结局

  • Complications(Time of the block to one week after the block)

研究者

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

Veronique Brulotte

Impact of the ultrasound-guided approach on the efficiency and safety of the stellate ganglion block in chronic pain

Maisonneuve-Rosemont Hospital

研究点 (2)

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