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Stellate Gnaglion Block in Refractory Bell's Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05094245
Recruitment Status : Completed
First Posted : October 26, 2021
Last Update Posted : October 6, 2022
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Facial Palsy Neuropathy Procedure: Stellate Ganglion Block Group Not Applicable

Detailed Description:

the conventional systemic 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) on idiopathic persistant facial nerve palsy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stellate Gnaglion Block Versus Conventional Therapey in Refractory Bell's Palsy; A Rondomized Single Blind Clinical Trial
Actual Study Start Date : November 1, 2021
Actual Primary Completion Date : May 30, 2022
Actual Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Stellate ganglion block
Patients underwent a stellate-ganglion block at the anterolateral aspect of the C6 vertebra. After local analgesia (lidocaine 2%), a 22-gauge Quincke needle was placed in the anterolateral aspect of the C6 vertebral body. When the needle contacted the bone, it was drawn back 1 mm. 5 mL of 0·5% ropivacaine was subsequently injected next to the stellate ganglion to produce a sympathetic block.The effect of the stellate-ganglion block on the sympathetic nervous system was confirmed by the presence of Horner's syndrome (ie, facial anhydrosis, enophthalmos, ptosis, swelling of the lower eyelid, miosis, and blood-shot conjunctiva), and an increase in the temperature of the right hand of at least 2°F from baseline.
Procedure: Stellate Ganglion Block Group
Patients underwent a stellate-ganglion block at the anterolateral aspect of the C6 vertebra. After local analgesia (lidocaine 2%), a 22-gauge Quincke needle was placed in the anterolateral aspect of the C6 vertebral body. When the needle contacted the bone, it was drawn back 1 mm. 5 mL of 0·5% ropivacaine was subsequently injected next to the stellate ganglion to produce a sympathetic block.The effect of the stellate-ganglion block on the sympathetic nervous system was confirmed by the presence of Horner's syndrome (ie, facial anhydrosis, enophthalmos, ptosis, swelling of the lower eyelid, miosis, and blood-shot conjunctiva), and an increase in the temperature of the right hand of at least 2°F from baseline.

No Intervention: Conventional
Mecobalamin Tablets oral Mecobalamin Tablets tid-8



Primary Outcome Measures :
  1. House Brackmann grading scale [ Time Frame: Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month ]

    The House-Brackmann scale is a nerve grading system, It is used to characterize the severity of a facial paralysis patient's symptoms.

    Grade I : 100% functioning Grade VI : 0% function



Secondary Outcome Measures :
  1. Likert scale [ Time Frame: before intervention , and directly after intervention ]
    Likert scale (Patients' satisfaction) is typically a five; 1 =strongly dis-satisfied and 5= strongly satisfied



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed by clinical and neurological assessment as one-sided idiopathic facial palsy
  • Age 18 to 60
  • ASA Ⅰ~Ⅲ

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05094245


Locations
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Egypt
Emad Zarief Kamel Said
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
Additional Information:
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Responsible Party: Emad Zarief , MD, professor, Assiut University
ClinicalTrials.gov Identifier: NCT05094245    
Other Study ID Numbers: IRB009999
First Posted: October 26, 2021    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emad Zarief , MD, Assiut University:
neuropathy
Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases