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Trigeminal NeuralgiaNCT06129071

Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

A study testing US guided block of maxillary nerve in people with Trigeminal Neuralgia, run by Varazdin General Hospital at 1 site in Croatia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a study about the dynamics and effects of ultrasound guided maxillary nerve block in trigeminal neuralgia Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Trigeminal Neuralgia
What is being tested?
US guided block of maxillary nerve
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCroatia
Study dates
1 Dec 2023to 1 Mar 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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with trigeminal neuralgia

Who cannot join

  • allergy to local anesthetics
  • local infection at the site of needle puncture
  • parotitis
  • serious liver disease
  • use of antiarrhythmics group III (eg amiodarone)
  • anticoagulant or antithrombotic drugs
  • lactation

Trial locations and contacts

1 site in 1 country.

Croatia1 site

  • Varazdin General Hospital

    Varaždin, 42000

Other trials in Croatia

About this study

Official title: Analgesic Effect Evaluation of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

This is a study about the dynamics and effects of ultrasound guided maxillary nerve block in trigeminal neuralgia

Read the detailed description

Standard pharmacological treatment for trigeminal neuralgia is often insufficient. In this setting, patients often suffer trough everyday activities and quality of life is disturbed substantially.

In this prospective clinical study, analgesic effect of ultrasound (US) guided maxillary nerve block will be investigated, in order to prolong pain-free time, reduce the use of standard analgesics, as well as atypical ones (e.g. antiepileptic drugs and antidepressants).

Characteristics of US guided maxillary nerve block will pain investigated: reduction of pain (decrease of VAS score), duration of pain-free period, pain level during the procedure.

Being tested
US guided block of maxillary nerve
Keywords
trigeminal neuralgia, maxillary nerve, ultrasound guided nerve block
Medical subject headings
Trigeminal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • US guided block of maxillary nerveProcedure or surgery

    Extraoral ultrasound-guided block of the maxillary nerve will be performed in the examined group using an ultrasound device and local anesthetic levobupivacaine (0,5%, 2 mL) combined with triamcinolonacetonid (2mL).

Study groups in NCT06129071
Study groupRoleWhat they receive
US block of maxillar nerveExperimentalExtraoral ultrasound-guided block of the maxillary nerve will be performed using an ultrasound device. After visualisation of the pterygomandibular space, of the maxillary artery and the mandibular nerve next to it, at a depth of 2-4 cm, the detection of the maxillary artery is confirmed by Color Doppler. A needle enters between the coronoid and condylar processes, using the "out of plane" technique, near the maxillary artery, and after negative aspiration, local anesthetic levobupivacaine (0,5%, 2 mL) combined with triamcinolonacetonid (2mL).
Receives: Procedure: US guided block of maxillary nerve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time without pain

    Patients will report to the investigator when pain starts to rise - and the amount of time form the procedure to the reporting will be recorded

    Measured: 26 weeks

Secondary outcomes (3)

  1. Trend of pain level

    Pain will be graded according to visual analogue scale, 0 meaning no pain, 10 meaning the worse pain possible

    Measured: Pain level at three time points: 1 month, 3 months and 6 months after the procedure

  2. Pain level when anesthesia is applied

    Pain will be graded according to visual analogue scale, 0 meaning no pain, 10 meaning the worse pain possible

    Measured: Immediately after the procedure

  3. Time to sart of the action of the block

    Time from the procedure till the pain is reduced, in minutes

    Measured: Immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Why it stopped: the principal investigator changed her mind and gave up from the study

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06129071
Sponsor's protocol ID
20061988
Status last verified
Nov 2023
First submitted
7 Nov 2023
Last updated
9 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Moore D, Chong MS, Shetty A, Zakrzewska JM. A systematic review of rescue analgesic strategies in acute exacerbations of primary trigeminal neuralgia. Br J Anaesth. 2019 Aug;123(2):e385-e396. doi: 10.1016/j.bja.2019.05.026. Epub 2019 Jun 15.

    PubMed 31208761

  • Al-Quliti KW. Update on neuropathic pain treatment for trigeminal neuralgia. The pharmacological and surgical options. Neurosciences (Riyadh). 2015 Apr;20(2):107-14. doi: 10.17712/nsj.2015.2.20140501.

    PubMed 25864062

  • Maarbjerg S, Di Stefano G, Bendtsen L, Cruccu G. Trigeminal neuralgia - diagnosis and treatment. Cephalalgia. 2017 Jun;37(7):648-657. doi: 10.1177/0333102416687280. Epub 2017 Jan 11.

    PubMed 28076964

  • Lee JY, Lee GH, Yi SH, Sim WS, Kim BW, Park HJ. Non-Surgical Treatments of Trigeminal Neuralgia from the Perspective of a Pain Physician: A Narrative Review. Biomedicines. 2023 Aug 21;11(8):2315. doi: 10.3390/biomedicines11082315.

    PubMed 37626811

  • Allam AE, Khalil AAF, Eltawab BA, Wu WT, Chang KV. Ultrasound-Guided Intervention for Treatment of Trigeminal Neuralgia: An Updated Review of Anatomy and Techniques. Pain Res Manag. 2018 Apr 2;2018:5480728. doi: 10.1155/2018/5480728. eCollection 2018.

    PubMed 29808105

  • Seo HJ, Park CK, Choi MK, Ryu J, Park BJ. Clinical Outcome of Percutaneous Trigeminal Nerve Block in Elderly Patients in Outpatient Clinics. J Korean Neurosurg Soc. 2020 Nov;63(6):814-820. doi: 10.3340/jkns.2020.0139. Epub 2020 Oct 27.

    PubMed 33105531

  • Love S, Coakham HB. Trigeminal neuralgia: pathology and pathogenesis. Brain. 2001 Dec;124(Pt 12):2347-60. doi: 10.1093/brain/124.12.2347.

    PubMed 11701590

  • Balta S, Koknel Talu G. Clinical effectiveness of peripheral nerve blocks with lidocaine and corticosteroid in patients with trigeminal neuralgia. Agri. 2021 Oct;33(4):237-242. doi: 10.14744/agri.2021.26032.

    PubMed 34671954

  • Ertilav E, Aydin ON. Evaluation of the effectiveness duration of peripheral blocks applied with high concentration local anesthetic and steroid in trigeminal neuralgia. Agri. 2022 Oct;34(4):264-271. doi: 10.14744/agri.2021.77854.

    PubMed 36300746

  • Kumar A, Sinha C, Kumar A, Kumari P, Mukul SK. Ultrasound-guided trigeminal nerve block and its comparison with conventional analgesics in patients undergoing faciomaxillary surgery: Randomised control trial. Indian J Anaesth. 2018 Nov;62(11):871-875. doi: 10.4103/ija.IJA_256_18.

    PubMed 30532323

  • Gunes A, Bulut E, Akgoz A, Mocan B, Gocmen R, Oguz KK. Trigeminal nerve and pathologies in magnetic resonance imaging - a pictorial review. Pol J Radiol. 2018 Jun 16;83:e289-e296. doi: 10.5114/pjr.2018.76921. eCollection 2018.

    PubMed 30627249

  • Jacques N, Karoutsos S, Marais L, Nathan-Denizot N. Quality of life after trigeminal nerve block in refractory trigeminal neuralgia: A retrospective cohort study and literature review. J Int Med Res. 2022 Oct;50(10):3000605221132027. doi: 10.1177/03000605221132027.

    PubMed 36281027

Questions about this trial

What is this clinical trial studying?

A study testing US guided block of maxillary nerve in people with Trigeminal Neuralgia, run by Varazdin General Hospital at 1 site in Croatia.

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 1 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: withdrawn, as of the sponsor's last update on 9 Apr 2024. 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 Croatia. 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 was withdrawn before enrolling participants, so there are no results.

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?

Time without pain (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06129071, which also lists 12 linked publications.

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 9 Apr 2024.

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