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Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis

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ClinicalTrials.gov Identifier: NCT04800666
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : March 16, 2021
Sponsor:
Information provided by (Responsible Party):
Zhuan Zhang, Yangzhou University

Study Description
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Brief Summary:
Peripheral facial palsy is caused by damage to the facial nerve at any site of the peripheral branches after the facial nucleus.Stellate ganglion block is performed to treat peripheral facial palsy because it increases blood flow and promotes nerve regeneration.Facial Nerve Block worked with elimination of local inflammation of nerve and oppression. Facial nerve block is a treatment that inject drugs into the damaged nerve around to eliminate local inflammation and compression of the nerve.

Condition or disease Intervention/treatment Phase
Peripheral Facial Palsy Procedure: Stellate Ganglion Block Procedure: Facial Nerve Block Drug: Mecobalamin Tablets Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Facial Nerve Block Group
Facial Nerve Block and oral Mecobalamin Tablets
 Procedure: Facial Nerve Block
Operator touching the location of the mastoid, in the external auditory canal just below the front of the mastoid vertical needling.When touch the surface of the mastoid,adjust the needle across the front of the mastoid then slow needling about 1cm.The pin located below the stylomastoid foramen, and then injected drugs 5mL ( mecobalamin injection 1mg；lidocaine 60mg； dexamethasone 10mg )

Drug: Mecobalamin Tablets
oral Mecobalamin Tablets tid-8
Experimental: Stellate Ganglion Block Group
Facial Nerve Block and Stellate Ganglion Block and oral Mecobalamin Tablets
 Procedure: 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: Facial Nerve Block
Operator touching the location of the mastoid, in the external auditory canal just below the front of the mastoid vertical needling.When touch the surface of the mastoid,adjust the needle across the front of the mastoid then slow needling about 1cm.The pin located below the stylomastoid foramen, and then injected drugs 5mL ( mecobalamin injection 1mg；lidocaine 60mg； dexamethasone 10mg )

Drug: Mecobalamin Tablets
oral Mecobalamin Tablets tid-8
Experimental: D Group
Facial Nerve Block
 Procedure: Facial Nerve Block
Operator touching the location of the mastoid, in the external auditory canal just below the front of the mastoid vertical needling.When touch the surface of the mastoid,adjust the needle across the front of the mastoid then slow needling about 1cm.The pin located below the stylomastoid foramen, and then injected drugs 5mL ( mecobalamin injection 1mg；lidocaine 60mg； dexamethasone 10mg )
C Group
control
 Drug: Mecobalamin Tablets
oral Mecobalamin Tablets tid-8


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline House-Brackmann [ Time Frame: Baseline ,change from baseline House-Brackmann at 3 days,6 days,9 days,14 days,one month,two month ]
    The House-Brackmann scale is a nerve grading system developed in 1985 by Los Angeles otolaryngologists Dr. John W. House and Dr. Derald E. Brackmann. It is used to characterize the severity of a facial paralysis patient's symptoms.

  2. Change from Baseline Sunnybrook [ Time Frame: Baseline,change from baseline Sunnybrook at 3 days,6 days,9 days,14 days, one month,two month ]
    Sunnybrook is a new facial nerve function of subjective assessment system.It is based on both static and dynamic aspects.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Diagnosed by clinical and neurological assessment as one-sided simple facial

  • Age 18 to 70 ASA Ⅰ~Ⅲ

Exclusion Criteria:

  • Coagulation dysfunction plate plate plate shape, quantity or abnormal function mental system diseases Gillan-Bahrain syndrome cancer, mumps, shingles infection, jaw facial pus lymph nodeitis, encephalitis, cerebral hemorrhage and other diseases Local infection or systemic infectious disease at the puncture site ASA rating greater than III. fail accept to nerve block
Contacts and Locations
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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): NCT04800666


Contacts
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Contact: zhuan zhang, professor +8615062791355 zhangzhuancg@163.com

Locations
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China, Jiangsu
the Affiliated Hospital of Yangzhou University Recruiting
Yangzhou, Jiangsu, China
Contact: zhuan zhang, professor    +8615062791355 ext +8615062791355    zhangzhuancg@163.com   
Sponsors and Collaborators
Yangzhou University
Investigators
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Principal Investigator: zhuan zhang, professor the Affiliated Hospital of Yangzhou University
More Information
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Responsible Party: Zhuan Zhang, Director, Yangzhou University
ClinicalTrials.gov Identifier: NCT04800666    
Other Study ID Numbers: 202103102
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021

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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 Zhuan Zhang, Yangzhou University:
Peripheral Facial Palsy
Stellate Ganglion Block
Facial Nerve Block
Additional relevant MeSH terms:
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Bell Palsy
Ganglion Cysts
Facial Paralysis
Paralysis
Facies
Disease Attributes
Pathologic Processes
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
 Neurologic Manifestations
Nervous System Diseases
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Facial Nerve Diseases
Cranial Nerve Diseases