Stellate Gnaglion Block in Refractory Bell's Palsy

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05094245
Collaborator
(none)
60
1
2
7.9
7.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stellate Ganglion Block Group
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Stellate Gnaglion Block Versus Conventional Therapey in Refractory Bell's Palsy; A Rondomized Single Blind Clinical Trial
Actual Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Procedure: Stellate Ganglion Block Group
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.

No Intervention: Conventional

Mecobalamin Tablets oral Mecobalamin Tablets tid-8

Outcome Measures

Primary Outcome Measures

  1. House Brackmann grading scale [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 Outcome Measures

  1. Likert scale [before intervention , and directly after intervention]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emad Zarief Kamel Said Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Emad Zarief , MD, professor, Assiut University
ClinicalTrials.gov Identifier:
NCT05094245
Other Study ID Numbers:
  • IRB009999
First Posted:
Oct 26, 2021
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Emad Zarief , MD, professor, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2022