Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique

Study Overview
=================
Brief Summary
-----------------
Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered a type of surgery, which involves the injection of glycerol in a nerve structure called trigeminal ganglion. The researchers will do a pilot study on 10 patients with a new surgical technique using neuronavigation. The researchers believe that this new neuronavigation-based system can improve the precision of the technique and reduce the risk for complications.

Official Title
-----------------
Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique

Conditions
-----------------
Trigeminal Neuralgia, Headache Disorders

Intervention / Treatment
-----------------
* Drug: Glycerol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed and written consent Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria Unsatisfactory effect of pharmacological treatment Exclusion Criteria: Microvascular decompression is seen as a better alternative Heart or lung disease Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection Psychiatric illness that hinders participation in the study Known pregnancy or breast feeding Inadequate use of contraceptives Overuse or abuse of opioids Abuse of medications, narcotics or alcohol Anomalies which hinder or impede the used method of injection Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Glycerol injection<br>The patients will be injected with glycerol using a new neuronavigation-based technique in the trigeminal ganglion. | Drug: Glycerol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Number of adverse events and number of participants with adverse events after glycerol injection in the trigeminal ganglion and severity of adverse events by the method used. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations. | For the follow-up period of 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of attacks with trigeminal neuralgia |  | 12 weeks | 
| Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale | expressed as score on Visual analogue scale (VAS) for pain | 12 weeks | 
| Intensity of the trigeminal neuralgia attacks assessed by questionnaire | expressed by means of patient global impression of change questionnaire (PGIC) | 12 weeks | 
| Number of doses of common analgesics | week 1-4, week 5-8, week 9-12 | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trigeminal ganglion, Glycerol, Nerve block