Stellate Gnaglion Block in Refractory Bell's Palsy

NCT05094245 | Completed

• 1 other identifier: IRB009999
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Facial Palsy; Neuropathy

Keywords

neuropathy

Outcome Measures

Primary Outcomes (1)

• House Brackmann grading scale

  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

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

Secondary Outcomes (1)

• Likert scale

  before intervention , and directly after intervention

Study Arms (2)

Stellate ganglion block

ACTIVE COMPARATOR

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.

Procedure: Stellate Ganglion Block Group

Conventional

NO INTERVENTION

Mecobalamin Tablets oral Mecobalamin Tablets tid-8

Interventions

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.

Stellate ganglion block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed by clinical and neurological assessment as one-sided idiopathic facial palsy
• Age 18 to 60
• ASA Ⅰ\~Ⅲ

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: October 26, 2021
• Study Start: November 1, 2021
• Primary Completion: May 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)