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| ID | Type | Description | Link |
|---|---|---|---|
| Tishreen University Hosital | Registry Identifier | Tsh-21 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-Guided Corticosteroid and Bupivacaine Injection | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone and Bupivacaine Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in facial nerve function using the House-Brackmann grading scale | 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. | 7 day, 15 days, and 3 months post-injection |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tishreen University Hospital | Latakia | Syria |
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| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D002045 | Bupivacaine |
| D000305 | Adrenal Cortex Hormones |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |