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Completed

NCT Number: NCT04800666

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

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.

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Key information

Conditions

Peripheral Facial Palsy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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 )

Mecobalamin Tablets

Drug

oral Mecobalamin Tablets tid-8

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Zhuan Zhang

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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