Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis
Primary Purpose
Peripheral Facial Palsy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stellate Ganglion Block
Facial Nerve Block
Mecobalamin Tablets
Sponsored by
About this trial
This is an interventional prevention trial for Peripheral Facial Palsy focused on measuring Peripheral Facial Palsy, Stellate Ganglion Block, Facial Nerve Block
Eligibility Criteria
Inclusion Criteria:
Diagnosed by clinical and neurological assessment as one-sided simple facial
- Age 18 to 75 years
- HBGS above Ⅳ
- the course of IFP not over 7 days.
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
- can not accept to nerve block
Sites / Locations
- the Affiliated Hospital of Yangzhou University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
Facial Nerve Block Group
Stellate Ganglion Block Group
D Group
C Group
Arm Description
Facial Nerve Block and oral Mecobalamin Tablets
Facial Nerve Block and Stellate Ganglion Block and oral Mecobalamin Tablets
Facial Nerve Block
control
Outcomes
Primary Outcome Measures
Change from Baseline House-Brackmann
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.
Change from Baseline Sunnybrook
Sunnybrook is a new facial nerve function of subjective assessment system.It is based on both static and dynamic aspects.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04800666
Brief Title
Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis
Official Title
Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhuan Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Facial Palsy
Keywords
Peripheral Facial Palsy, Stellate Ganglion Block, Facial Nerve Block
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Facial Nerve Block Group
Arm Type
Experimental
Arm Description
Facial Nerve Block and oral Mecobalamin Tablets
Arm Title
Stellate Ganglion Block Group
Arm Type
Experimental
Arm Description
Facial Nerve Block and Stellate Ganglion Block and oral Mecobalamin Tablets
Arm Title
D Group
Arm Type
Experimental
Arm Description
Facial Nerve Block
Arm Title
C Group
Arm Type
Other
Arm Description
control
Intervention Type
Procedure
Intervention Name(s)
Stellate Ganglion Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Facial Nerve Block
Intervention Description
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 )
Intervention Type
Drug
Intervention Name(s)
Mecobalamin Tablets
Intervention Description
oral Mecobalamin Tablets tid-8
Primary Outcome Measure Information:
Title
Change from Baseline House-Brackmann
Description
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.
Time Frame
Baseline ,change from baseline House-Brackmann at 3 days,6 days,9 days,14 days,one month,two month
Title
Change from Baseline Sunnybrook
Description
Sunnybrook is a new facial nerve function of subjective assessment system.It is based on both static and dynamic aspects.
Time Frame
Baseline,change from baseline Sunnybrook at 3 days,6 days,9 days,14 days, one month,two month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed by clinical and neurological assessment as one-sided simple facial
Age 18 to 75 years
HBGS above Ⅳ
the course of IFP not over 7 days.
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
can not accept to nerve block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhuan zhang, professor
Organizational Affiliation
The Affiliated Hospital of Yangzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Affiliated Hospital of Yangzhou University
City
Yangzhou
State/Province
Jiangsu
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis
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