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

NCT06955455 | Completed

• 2 other identifiers: N/2022-31Tishreen University Hosital
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bell's Palsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Drug: Triamcinolone and Bupivacaine Injection

Interventions

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.

Also known as: Corticosteroid and local anesthetic injection

Ultrasound-Guided Corticosteroid and Bupivacaine Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tishreen University Hospital: lead

Study Sites (1)

Tishreen University Hospital

Latakia, Syria

Location

MeSH Terms

Interventions

Triamcinolone; Bupivacaine; Adrenal Cortex Hormones; Anesthetics, Local

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 2, 2025
• Study Start: January 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

SY (1)