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CompletedNCT06955455Updated May 2, 2025

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

An interventional study of Triamcinolone and Bupivacaine Injection in Bell's Palsy, sponsored by Tishreen University Hospital. Completed at 1 site in Syria. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-02.

Sponsored by Tishreen University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Jan 2022, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Bell's Palsy
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In context

Lead sponsor

Tishreen University Hospital is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

Interventions

  • DrugTriamcinolone and Bupivacaine Injection

    Drug pages: Triamcinolone · Bupivacaine

    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

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What researchers measure

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.

    Time frame: 7 day, 15 days, and 3 months post-injection

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Study locations

1 site
  • Tishreen University Hospital
    Latakia, Syria
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06955455
Lead sponsor
Tishreen University Hospital
Responsible party
Ali Hammed (Dr, Tishreen University Hospital) — Principal investigator
First posted
May 2, 2025
Start date
Jan 1, 2022
Primary completion
Oct 1, 2024
Completion
Feb 1, 2025
Last update
May 2, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Triamcinolone · Bupivacaine

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