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the principal investigator changed her mind and gave up from the study
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This is a study about the dynamics and effects of ultrasound guided maxillary nerve block in trigeminal neuralgia
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US block of maxillar nerve | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| US guided block of maxillary nerve | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain level when anesthesia is applied |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monika Kocman Panic | Varazdin General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Varazdin General Hospital | Varaždin | 42000 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31208761 | Background | 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. | |
| 25864062 | Background | 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. |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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Pain will be graded according to visual analogue scale, 0 meaning no pain, 10 meaning the worse pain possible |
| Immediately after the procedure |
| Time to sart of the action of the block | Time from the procedure till the pain is reduced, in minutes | Immediately after the procedure |
| 28076964 | Background | 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. |
| 37626811 | Background | 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. |
| 29808105 | Background | 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. |
| 33105531 | Background | 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. |
| 11701590 | Background | Love S, Coakham HB. Trigeminal neuralgia: pathology and pathogenesis. Brain. 2001 Dec;124(Pt 12):2347-60. doi: 10.1093/brain/124.12.2347. |
| 34671954 | Background | 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. |
| 36300746 | Background | 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. |
| 30532323 | Background | 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. |
| 30627249 | Background | 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. |
| 36281027 | Background | 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. |
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |