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

Effectiveness of Ultrasound-Guided Corticosteroid and Bupivacaine Injections on Facial Nerve Function and Thickness in Acute Bell's Palsy: A Preliminary Trial

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.

Study Overview

• Status: Completed
• Conditions: Bell's Palsy
• Intervention / Treatment: Drug: Triamcinolone and Bupivacaine Injection

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Latakia, Syrian Arab Republic
    • Tishreen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: 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 Names: Corticosteroid and local anesthetic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tishreen University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 24, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cranial Nerve Diseases; Facial Nerve Diseases; Bell Palsy; Physiological Effects of Drugs; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Central Nervous System Depressants; Sensory System Agents; Bupivacaine; Anesthetics; Anesthetics, Local; Triamcinolone
• Other Study ID Numbers: N/2022-31; Tishreen University Hosital (Registry Identifier: Tsh-21)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No