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Completed

NCT Number: NCT05094245

Stellate Gnaglion Block in Refractory Bell's Palsy

Idiopathic facial nerve palsy (Bell's palsy) is caused by damage to the facial nerve at any site of the peripheral branches after the facial nucleus.Stellate ganglion block is inteneded to increase blood flow and promotes nerve regeneration.

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Key information

Conditions

Facial Palsy Facial Paralysis Mouth Diseases Nervous System Diseases Neurologic Manifestations Neuropathy Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emad Zarief Kamel Said

Asyut, 71111, Egypt

About this study

the conventional systemic corticosteroid treatment for acute peripheral facial nerve palsy in patients can induce hyperglycemia, and an alternative local therapy may be necessary and some time may ve ineffective.

Our purpose in this study is to evaluate therapeutic effects of stellate ganglion block (SGB) on idiopathic persistant facial nerve palsy.

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 idiopathic facial palsy
  • Age 18 to 60
  • ASA Ⅰ~Ⅲ

Exclusion criteria

  • diabetic
  • coagulation dysfunction
  • mental or cognitive dysfunclion
  • allergy to injected medication

Treatment and study plan

Stellate ganglion block group

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.

Primary outcomes

  1. House Brackmann grading scale

    Time frame: Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month

    The House-Brackmann scale is a nerve grading system, It is used to characterize the severity of a facial paralysis patient's symptoms.

    Grade I : 100% functioning Grade VI : 0% function

Secondary outcomes

  1. Likert scale

    Time frame: before intervention , and directly after intervention

    Likert scale (Patients' satisfaction) is typically a five; 1 =strongly dis-satisfied and 5= strongly satisfied

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Stellate Gnaglion Block Versus Conventional Therapey in Refractory Bell's Palsy; A Rondomized Single Blind Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2021
Registry last updated
Oct 6, 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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