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

November 20, 2022 updated by: Zhuan Zhang
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Yangzhou, Jiangsu, China
        • the Affiliated Hospital of Yangzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facial Nerve Block Group
Facial Nerve Block and oral Mecobalamin Tablets
Drug: Mecobalamin Tablets
oral Mecobalamin Tablets tid-8
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 )
Experimental: Stellate Ganglion Block Group
Facial Nerve Block and Stellate Ganglion Block and oral Mecobalamin Tablets
Drug: Mecobalamin Tablets
oral Mecobalamin Tablets tid-8
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 )
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline House-Brackmann
Time Frame: 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.
Baseline ,change from baseline House-Brackmann at 3 days,6 days,9 days,14 days,one month,two month
Change from Baseline Sunnybrook
Time Frame: 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.
Baseline,change from baseline Sunnybrook at 3 days,6 days,9 days,14 days, one month,two month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhuan Zhang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 13, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 20, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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