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

NCT04800666 | Completed

• 1 other identifier: 202103102
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Peripheral Facial Palsy; Stellate Ganglion Block; Facial Nerve Block

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

Facial Nerve Block Group

EXPERIMENTAL

Facial Nerve Block and oral Mecobalamin Tablets

Procedure: Facial Nerve Block; Drug: Mecobalamin Tablets

Stellate Ganglion Block Group

EXPERIMENTAL

Facial Nerve Block and Stellate Ganglion Block and oral Mecobalamin Tablets

Procedure: Stellate Ganglion Block; Procedure: Facial Nerve Block; Drug: Mecobalamin Tablets

D Group

EXPERIMENTAL

Facial Nerve Block

Procedure: Facial Nerve Block

C Group

OTHER

control

Drug: Mecobalamin Tablets

Interventions

Stellate Ganglion Block 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.

Stellate Ganglion Block Group

Facial Nerve Block 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 )

D Group; Facial Nerve Block Group; Stellate Ganglion Block Group

Mecobalamin Tablets DRUG

oral Mecobalamin Tablets tid-8

C Group; Facial Nerve Block Group; Stellate Ganglion Block Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Location

MeSH Terms

Interventions

mecobalamin

Study Officials

• zhuan zhang, professor

  The Affiliated Hospital of Yangzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: March 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

CN (1)