Stellate Gnaglion Block in Refractory Bell's Palsy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Facial Palsy, Neuropathy

Intervention / Treatment
-----------------
* Procedure: Stellate Ganglion Block Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed by clinical and neurological assessment as one-sided idiopathic facial palsy Age 18 to 60 ASA Ⅰ Ⅲ Exclusion Criteria: diabetic coagulation dysfunction mental or cognitive dysfunclion allergy to injected medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stellate ganglion block<br>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. | Procedure: Stellate Ganglion Block Group<br>* 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.<br>|
| No Intervention: Conventional<br>Mecobalamin Tablets oral Mecobalamin Tablets tid-8 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| House Brackmann grading scale | 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 | Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert scale | Likert scale (Patients' satisfaction) is typically a five; 1 =strongly dis-satisfied and 5= strongly satisfied | before intervention , and directly after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropathy