Ultrasound-Guided Stellate Ganglion Block With Botulinum

NCT ID: NCT05099835

Last Updated: 2022-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-07-01

Brief Summary

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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

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: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

Conditions

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Change From Baseline House-Brackmann

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Botulinum Toxin

injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)

Group Type ACTIVE_COMPARATOR

Botox

Intervention Type DRUG

injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)

steroid

injected 10 mL of 0.25% bupivacaine with triamcinolonacetonide 4 mg/ml

Group Type ACTIVE_COMPARATOR

triamcinolonacetonide

Intervention Type DRUG

triamcinolonacetonide stellate ganglion injection

Interventions

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Botox

injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)

Intervention Type DRUG

triamcinolonacetonide

triamcinolonacetonide stellate ganglion injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* diabetic
* coagulation dysfunction
* mental or cognitive dysfunclion
* allergy to injected medication
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Emad Zarief , MD

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emad Zarief Kamel Said

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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000092

Identifier Type: -

Identifier Source: org_study_id

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