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Ultrasound-Guided Stellate Ganglion Block With Botulinum

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05099835
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
8
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ultrasound-Guided Stellate Ganglion Block With Botulinum Toxin Versus Steroid in Refractory Bell's Palsy
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Botulinum Toxin

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

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

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

Drug: triamcinolonacetonide
triamcinolonacetonide stellate ganglion injection

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emad Zarief Kamel Said Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emad Zarief , MD, professor, Assiut University
ClinicalTrials.gov Identifier:
NCT05099835
Other Study ID Numbers:
  • 000092
First Posted:
Oct 29, 2021
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Ganglion Cysts

Study Results

No Results Posted as of Jan 14, 2022