Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06129071
• Other study ID #: 20061988
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2023
• Source: Varazdin General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Procedure:
• 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).

Locations

Country	Name	City	State
Croatia	Varazdin General Hospital	Varaždin

Sponsors (1)

Lead Sponsor	Collaborator
Varazdin General Hospital

Country where clinical trial is conducted

Croatia, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Love S, Coakham HB. Trigeminal neuralgia: pathology and pathogenesis. Brain. 2001 Dec;124(Pt 12):2347-60. doi: 10.1093/brain/124.12.2347. Erratum In: Brain 2002 Mar;125(Pt 3):687. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	26 weeks
Secondary	Trend of pain level	Pain will be graded according to visual analogue scale, 0 meaning no pain, 10 meaning the worse pain possible	Pain level at three time points: 1 month, 3 months and 6 months after the procedure
Secondary	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	Immediately after the procedure
Secondary	Time to sart of the action of the block	Time from the procedure till the pain is reduced, in minutes	Immediately after the procedure