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

Peripheral Facial Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800666
• Other study ID #: 202103102
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: November 2022
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

• Age 18 to 75 years
• HBGS above ?
• 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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Facies
• Ganglion Cysts
• Paralysis
• Peripheral Facial Palsy

Intervention

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.
• 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

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline ,change from baseline House-Brackmann at 3 days,6 days,9 days,14 days,one month,two month
Primary	Change from Baseline Sunnybrook	Sunnybrook is a new facial nerve function of subjective assessment system.It is based on both static and dynamic aspects.	Baseline,change from baseline Sunnybrook at 3 days,6 days,9 days,14 days, one month,two month