Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04800666
Other study ID # 202103102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date March 30, 2022

Study information

Verified date November 2022
Source Yangzhou University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date March 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: Diagnosed by clinical and neurological assessment as one-sided simple facial - Age 18 to 75 years - HBGS above ? - 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 Design


Intervention

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.
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 )
Drug:
Mecobalamin Tablets
oral Mecobalamin Tablets tid-8

Locations

Country Name City State
China the Affiliated Hospital of Yangzhou University Yangzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Zhuan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT05547152 - Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis N/A
Recruiting NCT06430034 - Contributions of 3D Photography and Stereophotogrammetry to the Evaluation of Facial Symmetrization by Botulinum Toxin Injections. Study of Facial Symmetry Before and After Botulinum Toxin Injections on the Face of Patients Suffering From Sequellar Peripheral Facial Paralysis
Recruiting NCT05191719 - Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy N/A