Ultrasound-Guided Stellate Ganglion Block With Botulinum Toxin Versus Steroid in Refractory Bell's Palsy
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
- Change from Baseline House-Brackmann
研究概览
简要总结
the local stellate ganglion block with bupivacaine and 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) Botulinum Toxin on referactory facial nerve palsy
详细描述
: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. the local stellate ganglion block with bupivacaine and 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) Botulinum Toxin on referactory 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
- Triple (Participant, 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 •-ASA i-II
排除标准
- •Exclusion Criteria:
- •coagulation dysfunction
- •mental or cognitive dysfunclion
- •allergy to injected medication
研究组 & 干预措施
Botulinum Toxin
injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)
干预措施: Botox (Drug)
steroid
injected 10 mL of 0.25% bupivacaine with triamcinolonacetonide 4 mg/ml
干预措施: triamcinolonacetonide (Drug)
结局指标
主要结局
Change from Baseline House-Brackmann
时间窗: : Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month
Change from Baseline House-Brackmann
次要结局
未报告次要终点
研究者
Emad Zarief , MD
professor
Assiut University