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临床试验/NCT05094245
NCT05094245已完成不适用

Stellate Gnaglion Block Versus Conventional Therapey in Refractory Bell's Palsy; A Rondomized Single Blind Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年11月1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
60
试验地点
1
主要终点
House Brackmann grading scale

研究概览

简要总结

Idiopathic facial nerve palsy (Bell's palsy) is caused by damage to the facial nerve at any site of the peripheral branches after the facial nucleus.Stellate ganglion block is inteneded to increase blood flow and promotes nerve regeneration.

详细描述

the conventional systemic corticosteroid treatment for acute peripheral facial nerve palsy in patients can induce hyperglycemia, and an alternative local therapy may be necessary and some time may ve ineffective.

Our purpose in this study is to evaluate therapeutic effects of stellate ganglion block (SGB) on idiopathic persistant facial nerve palsy.

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 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed by clinical and neurological assessment as one-sided idiopathic facial palsy
  • •Age 18 to 60

排除标准

  • •coagulation dysfunction
  • •mental or cognitive dysfunclion
  • •allergy to injected medication

研究组 & 干预措施

Stellate ganglion block

Active Comparator

Patients underwent a stellate-ganglion block at the anterolateral aspect of the C6 vertebra. After local analgesia (lidocaine 2%), a 22-gauge Quincke needle was placed in the anterolateral aspect of the C6 vertebral body. When the needle contacted the bone, it was drawn back 1 mm. 5 mL of 0·5% ropivacaine was subsequently injected next to the stellate ganglion to produce a sympathetic block.The effect of the stellate-ganglion block on the sympathetic nervous system was confirmed by the presence of Horner's syndrome (ie, facial anhydrosis, enophthalmos, ptosis, swelling of the lower eyelid, miosis, and blood-shot conjunctiva), and an increase in the temperature of the right hand of at least 2°F from baseline.

干预措施: Stellate Ganglion Block Group (Procedure)

Conventional

No Intervention

Mecobalamin Tablets oral Mecobalamin Tablets tid-8

结局指标

主要结局

House Brackmann grading scale

时间窗: Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month

The House-Brackmann scale is a nerve grading system, It is used to characterize the severity of a facial paralysis patient's symptoms. Grade I : 100% functioning Grade VI : 0% function

次要结局

  • Likert scale(before intervention , and directly after intervention)

研究者

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

Emad Zarief , MD

professor

Assiut University

研究点 (1)

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