Ultrasound-Guided Corticosteroid and Bupivacaine for Facial Nerve Function and Thickness in Bell's Palsy
NCT ID: NCT06955455
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-01-01
2025-02-01
Brief Summary
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A total of 40 adult participants diagnosed within 72 hours of symptom onset will be enrolled. The primary outcome is improvement in facial nerve function, assessed using the House-Brackmann Facial Nerve Grading System at day 7, day 15, and 3 months post-injection. Secondary outcomes include changes in facial nerve thickness measured by ultrasound before and one week after the procedure.
This is the first clinical trial to directly evaluate targeted facial nerve injection as a potential treatment approach in Bell's palsy.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ultrasound-Guided Corticosteroid and Bupivacaine Injection
Participants in this arm will receive a single, ultrasound-guided injection of 1 cc of 0.25% bupivacaine combined with 2 cc (20 mg) of triamcinolone (40 mg/mL). The injection is administered directly to the facial nerve (7th cranial nerve) approximately 1.5-2 cm distal to the stylomastoid foramen, in an inferior-anterior direction, under real-time ultrasound guidance. The goal is to reduce inflammation and accelerate recovery in patients with acute Bell's palsy.
Triamcinolone and Bupivacaine Injection
A single injection consisting of 1 cc of 0.25% bupivacaine mixed with 2 cc (20 mg) of triamcinolone (40 mg/mL) is administered under ultrasound guidance. The injection targets the extratemporal portion of the facial nerve approximately 1.5-2 cm distal to the stylomastoid foramen in an inferior and anterior direction. The intervention is designed to reduce inflammation and pain, potentially accelerating facial nerve recovery in acute Bell's palsy.
Interventions
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Triamcinolone and Bupivacaine Injection
A single injection consisting of 1 cc of 0.25% bupivacaine mixed with 2 cc (20 mg) of triamcinolone (40 mg/mL) is administered under ultrasound guidance. The injection targets the extratemporal portion of the facial nerve approximately 1.5-2 cm distal to the stylomastoid foramen in an inferior and anterior direction. The intervention is designed to reduce inflammation and pain, potentially accelerating facial nerve recovery in acute Bell's palsy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Diagnosis of acute Bell's palsy within the past 72 hours
House-Brackmann Grade III or higher
Willing and able to give informed consent
Able to attend all follow-up assessments
Exclusion Criteria
Known allergies to corticosteroids or local anesthetics
Coagulopathy or current use of anticoagulant therapy
MRI or CT findings indicating alternative causes of facial nerve palsy (e.g., tumor, stroke, MS)
Pregnancy or breastfeeding
Participation in another interventional clinical trial
\-
18 Years
70 Years
ALL
No
Sponsors
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Tishreen University Hospital
OTHER
Responsible Party
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Ali Hammed
Dr
Locations
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Tishreen University Hospital
Latakia, , Syria
Countries
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Other Identifiers
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Tishreen University Hosital
Identifier Type: REGISTRY
Identifier Source: secondary_id
N/2022-31
Identifier Type: -
Identifier Source: org_study_id
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