NCT05099835

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 18, 2021

Last Update Submit

October 5, 2022

Conditions

Change From Baseline House-Brackmann

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline House-Brackmann

    Change from Baseline House-Brackmann

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

Study Arms (2)

Botulinum Toxin

ACTIVE COMPARATOR

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

Drug: Botox

steroid

ACTIVE COMPARATOR

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

Drug: triamcinolonacetonide

Interventions

BotoxDRUG

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

Botulinum Toxin
triamcinolonacetonideDRUG

triamcinolonacetonide stellate ganglion injection

steroid

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • diabetic
  • coagulation dysfunction
  • mental or cognitive dysfunclion
  • allergy to injected medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 29, 2021

Study Start

November 1, 2021

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

October 6, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)