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CompletedNCT05099835Updated Oct 6, 2022

Ultrasound-Guided Stellate Ganglion Block With Botulinum

An interventional study of Botox and triamcinolonacetonide in Change From Baseline House-Brackmann, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-06.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Change From Baseline House-Brackmann

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03

In context

Ganglion Cysts

136 studies on the registry are indexed under Ganglion Cysts; 28 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 101 interventional studies indexed under Ganglion Cysts.

Browse Ganglion Cysts studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Botulinum Toxin

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

    Drug: Botox

  • Active comparator
    steroid

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

    Drug: triamcinolonacetonide

Interventions

  • DrugBotox

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

  • Drugtriamcinolonacetonide

    triamcinolonacetonide stellate ganglion injection

06

What researchers measure

Primary outcomes

  1. Change from Baseline House-Brackmann

    Change from Baseline House-Brackmann

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

07

Study locations

1 site
  • Emad Zarief Kamel Said
    Assiut, 71111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05099835
Lead sponsor
Assiut University
Responsible party
Emad Zarief , MD (professor, Assiut University) — Principal investigator
First posted
Oct 29, 2021
Start date
Nov 1, 2021
Primary completion
Jun 1, 2022
Completion
Jul 1, 2022
Last update
Oct 6, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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