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

Tishreen University Hospital

Status: Completed

Conditions: Bell's Palsy

Treatments: Drug: Triamcinolone and Bupivacaine Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06955455

N/2022-31

Tishreen University Hosital (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Age between 18 and 70 years

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:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Ultrasound-Guided Corticosteroid and Bupivacaine Injection

Experimental group

Description:

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.

Treatment:

Drug: Triamcinolone and Bupivacaine Injection