Stellate Gnaglion Block in Refractory Bell's Palsy

Not Applicable

Completed

• Conditions: Facial Palsy; Neuropathy
• Interventions: Procedure: Stellate Ganglion Block Group

• Registration Number: NCT05094245
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-10-13
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-26
• Study Start: 2021-11-01
• Primary Completion: 2022-05-30
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stellate ganglion block	Stellate Ganglion Block Group	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.

Primary Outcome Measures

Name	Time	Method
House Brackmann grading scale	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

Secondary Outcome Measures

Name	Time	Method
Likert scale	before intervention , and directly after intervention	Likert scale (Patients' satisfaction) is typically a five; 1 =strongly dis-satisfied and 5= strongly satisfied

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt