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Ultrasound-Guided Corticosteroid and Bupivacaine for Facial Nerve Function and Thickness in Bell's Palsy

Not Applicable
Completed
Conditions
Bell's Palsy
Interventions
Drug: Triamcinolone and Bupivacaine Injection
Registration Number
NCT06955455
Lead Sponsor
Tishreen University Hospital
Brief Summary

This prospective, single-arm clinical study aims to evaluate the effects of a one-time, ultrasound-guided injection of corticosteroid (triamcinolone) combined with local anesthetic (bupivacaine) into the facial nerve in patients with acute Bell's palsy. The injection is administered approximately 1.5-2 cm after the nerve exits the stylomastoid foramen, with precise targeting using ultrasound imaging.

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

History of chronic facial nerve disorders

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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Ultrasound-Guided Corticosteroid and Bupivacaine InjectionTriamcinolone and Bupivacaine InjectionParticipants 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.
Primary Outcome Measures
NameTimeMethod
Improvement in facial nerve function using the House-Brackmann grading scale7 day, 15 days, and 3 months post-injection

Facial nerve function will be assessed using the House-Brackmann Facial Nerve Grading System, a standardized clinical scale for measuring the severity of facial paralysis. Participants will be evaluated at three time points: 7 day, 15 days, and 3 months after injection. A reduction in grade indicates improvement in nerve function. This outcome will determine whether ultrasound-guided corticosteroid and bupivacaine injection accelerates recovery in acute Bell's palsy.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Tishreen University Hospital

🇸🇾

Latakia, Syrian Arab Republic

Tishreen University Hospital
🇸🇾Latakia, Syrian Arab Republic

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