Bell's Palsy
Conditions
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.
Interventions
DRUGTriamcinolone 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.
Sponsors
Tishreen University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in facial nerve function using the House-Brackmann grading scale | 7 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. |
Countries
Syria
Outcome results
None listed