Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

NCT ID: NCT06129071

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-03-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Trigeminal Neuralgia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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US block of maxillar nerve

Extraoral 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).

Group Type EXPERIMENTAL

US guided block of maxillary nerve

Intervention Type PROCEDURE

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).

Interventions

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US guided block of maxillary nerve

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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with trigeminal neuralgia

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varazdin General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Monika Kocman Panic

Role: PRINCIPAL_INVESTIGATOR

Varazdin General Hospital

Locations

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Varazdin General Hospital

Varaždin, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type BACKGROUND
PMID: 31208761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25864062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28076964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37626811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29808105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33105531 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11701590 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34671954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36300746 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30532323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30627249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36281027 (View on PubMed)

Other Identifiers

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20061988

Identifier Type: -

Identifier Source: org_study_id

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