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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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