Analgesic Effect of Ultrasound Guided Maxillary Nerve Block in Trigeminal Neuralgia

Study Overview
=================
Brief Summary
-----------------
This is a study about the dynamics and effects of ultrasound guided maxillary nerve block in trigeminal neuralgia

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.

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

Conditions
-----------------
Trigeminal Neuralgia

Intervention / Treatment
-----------------
* Procedure: US guided block of maxillary nerve


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US block of maxillar nerve<br>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). | Procedure: US guided block of maxillary nerve<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trigeminal neuralgia, maxillary nerve, ultrasound guided nerve block