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Ultrasound-Guided Stellate Ganglion Block With Botulinum

Primary Purpose

Change From Baseline House-Brackmann

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Botox
triamcinolonacetonide
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Change From Baseline House-Brackmann

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emad Zarief Kamel Said

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Botulinum Toxin

steroid

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from Baseline House-Brackmann
Change from Baseline House-Brackmann

Secondary Outcome Measures

Full Information

First Posted
October 18, 2021
Last Updated
October 5, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05099835
Brief Title
Ultrasound-Guided Stellate Ganglion Block With Botulinum
Official Title
Ultrasound-Guided Stellate Ganglion Block With Botulinum Toxin Versus Steroid in Refractory Bell's Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Change From Baseline House-Brackmann

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botulinum Toxin
Arm Type
Active Comparator
Arm Description
injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)
Arm Title
steroid
Arm Type
Active Comparator
Arm Description
injected 10 mL of 0.25% bupivacaine with triamcinolonacetonide 4 mg/ml
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
injected 10 mL of 0.1% bupivacaine with 100 Botox units (BOTOX®, Allergan Inc., Irvine, CA, USA)
Intervention Type
Drug
Intervention Name(s)
triamcinolonacetonide
Intervention Description
triamcinolonacetonide stellate ganglion injection
Primary Outcome Measure Information:
Title
Change from Baseline House-Brackmann
Description
Change from Baseline House-Brackmann
Time Frame
: Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound-Guided Stellate Ganglion Block With Botulinum

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