Ultrasound-Guided Stellate Ganglion Block With Botulinum

Not Applicable

Completed

• Conditions: Change From Baseline House-Brackmann
• Interventions: Drug: Botox; Drug: triamcinolonacetonide

• Registration Number: NCT05099835
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

: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

Study Timeline

• Study First Submitted: 2021-10-18
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Start: 2021-11-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-01
• 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-II

Exclusion Criteria

• 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
Botulinum Toxin	Botox	injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)
steroid	triamcinolonacetonide	injected 10 mL of 0.25% bupivacaine with triamcinolonacetonide 4 mg/ml

Primary Outcome Measures

Name	Time	Method
Change from Baseline House-Brackmann	: Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month	Change from Baseline House-Brackmann

Trial Locations

Locations (1)

Emad Zarief Kamel Said; 🇪🇬 Assiut, Egypt