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

NCT ID: NCT04800666

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-03-30

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.

Conditions

Peripheral Facial Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Facial Nerve Block Group

Facial Nerve Block and oral Mecobalamin Tablets

Group Type: EXPERIMENTAL

Facial Nerve Block

Intervention Type: PROCEDURE

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 )

Mecobalamin Tablets

Intervention Type: DRUG

oral Mecobalamin Tablets tid-8

Stellate Ganglion Block Group

Facial Nerve Block and Stellate Ganglion Block and oral Mecobalamin Tablets

Group Type: EXPERIMENTAL

Stellate Ganglion Block

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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 )

Mecobalamin Tablets

Intervention Type: DRUG

oral Mecobalamin Tablets tid-8

D Group

Facial Nerve Block

Group Type: EXPERIMENTAL

Facial Nerve Block

Intervention Type: PROCEDURE

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

Group Type: OTHER

Mecobalamin Tablets

Intervention Type: DRUG

oral Mecobalamin Tablets tid-8

Interventions

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.

Intervention Type: 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 )

Intervention Type: PROCEDURE

Mecobalamin Tablets

oral Mecobalamin Tablets tid-8

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhuan Zhang

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

zhuan zhang, professor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Yangzhou University

Locations

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

202103102

Identifier Type: -

Identifier Source: org_study_id