Peripheral Facial PalsyNCT04800666
Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis
A study testing Stellate Ganglion Block, Facial Nerve Block and Mecobalamin Tablets in people with Peripheral Facial Palsy, run by Zhuan Zhang at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Facial Palsy
- What is being tested?
- Stellate Ganglion Block, Facial Nerve Block and Mecobalamin Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Stellate Ganglion Block, Facial Nerve Block, Mecobalamin Tablets
- Keywords
- Peripheral Facial Palsy, Stellate Ganglion Block, Facial Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
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 BlockProcedure or surgery
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 TabletsDrug
oral Mecobalamin Tablets tid-8
| Study group | Role | What they receive |
|---|---|---|
| Facial Nerve Block Group | Experimental | Facial Nerve Block and oral Mecobalamin Tablets Receives: Procedure: Facial Nerve Block; Drug: Mecobalamin Tablets |
| Stellate Ganglion Block Group | Experimental | Facial Nerve Block and Stellate Ganglion Block and oral Mecobalamin Tablets Receives: Procedure: Stellate Ganglion Block; Procedure: Facial Nerve Block; Drug: Mecobalamin Tablets |
| D Group | Experimental | Facial Nerve Block Receives: Procedure: Facial Nerve Block |
| C Group | Other | control Receives: Drug: Mecobalamin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline,change from baseline Sunnybrook at 3 days,6 days,9 days,14 days, one month,two month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Facial PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
- Investigators
- zhuan zhang, professor, Principal investigator, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800666
- Sponsor's protocol ID
- 202103102
- Status last verified
- Nov 2022
- First submitted
- 11 Mar 2021
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis
- ClinicalTrials.gov ID
- NCT04800666
- Acronym / sponsor ID
- 202103102
- Conditions
- Peripheral Facial Palsy
- Keywords
- Peripheral Facial Palsy, Stellate Ganglion Block, Facial Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Facial Nerve Block Group | Experimental | Procedure: Facial Nerve Block, Drug: Mecobalamin TabletsFacial Nerve Block and oral Mecobalamin Tablets |
| Stellate Ganglion Block Group | Experimental | Procedure: Stellate Ganglion Block, Procedure: Facial Nerve Block, Drug: Mecobalamin TabletsFacial Nerve Block and Stellate Ganglion Block and oral Mecobalamin Tablets |
| D Group | Experimental | Procedure: Facial Nerve BlockFacial Nerve Block |
| C Group | Other | Drug: Mecobalamin Tabletscontrol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion BlockPatients 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. | Procedure or surgery | Stellate Ganglion Block Group |
| Facial Nerve BlockOperator 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 or surgery | D Group, Facial Nerve Block Group, Stellate Ganglion Block Group |
| Mecobalamin Tabletsoral Mecobalamin Tablets tid-8 | Drug | C Group, Facial Nerve Block Group, Stellate Ganglion Block Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhuan zhang, professor principal investigator
Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate Ganglion Block, Facial Nerve Block and Mecobalamin Tablets in people with Peripheral Facial Palsy, run by Zhuan Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.