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

Sponsor

Yangzhou University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04800666

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Facial Palsy	Procedure: Stellate Ganglion Block Procedure: Facial Nerve Block Drug: Mecobalamin Tablets	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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 )
Other: C Group control	Drug: Mecobalamin Tablets oral Mecobalamin Tablets tid-8

Outcome Measures

Primary Outcome Measures

Change from Baseline House-Brackmann [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.
Change from Baseline Sunnybrook [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

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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