Bell's PalsyNCT06955455
Ultrasound-Guided Corticosteroid and Bupivacaine for Facial Nerve Function and Thickness in Bell's Palsy
A study testing Triamcinolone and Bupivacaine Injection in people with Bell's Palsy, run by Tishreen University Hospital at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- Triamcinolone and Bupivacaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2022to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bell's Palsy
- Being tested
- Triamcinolone and Bupivacaine Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone and Bupivacaine InjectionDrug
Also called Corticosteroid and local anesthetic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Triamcinolone and Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 day, 15 days, and 3 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start1 Jan 2022
- Primary completion1 Oct 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell's PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tishreen University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Hammed, Tishreen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955455
- Sponsor's protocol ID
- N/2022-31
- Other IDs
- Tishreen University Hosital
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-Guided Corticosteroid and Bupivacaine Injections on Facial Nerve Function and Thickness in Acute Bell's Palsy: A Preliminary Trial
- ClinicalTrials.gov ID
- NCT06955455
- Acronym / sponsor ID
- N/2022-31
- Conditions
- Bell's Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tishreen University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Corticosteroid and Bupivacaine Injection | Experimental | Drug: Triamcinolone and Bupivacaine InjectionParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone and Bupivacaine InjectionAlso: Corticosteroid and local anesthetic injectionA 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. | Drug | Ultrasound-Guided Corticosteroid and Bupivacaine Injection |
Primary outcome
Improvement in facial nerve function using the House-Brackmann grading scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Bell's Palsy
Enrolling by invitation
EXPLORING EFFECTIVENESS OF LOW LEVEL LASER THERAPY IN THE TREATMENT OF PATIENTS WITH BELLS PALSY
Bell Palsy, Bell's Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone and Bupivacaine Injection in people with Bell's Palsy, run by Tishreen University Hospital at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in facial nerve function using the House-Brackmann grading scale (time frame: 7 day, 15 days, and 3 months post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.