Trigeminal Neuralgia, Headache Disorders
Conditions
Keywords
Trigeminal ganglion, Glycerol, Nerve block
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.
Interventions
DRUGGlycerol
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | For the follow-up period of 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attacks with trigeminal neuralgia | 12 weeks | — |
| Intensity of the trigeminal neuralgia attacks assessed by Visual analogue scale | 12 weeks | expressed as score on Visual analogue scale (VAS) for pain |
| Intensity of the trigeminal neuralgia attacks assessed by questionnaire | 12 weeks | expressed by means of patient global impression of change questionnaire (PGIC) |
| Number of doses of common analgesics | 12 weeks | week 1-4, week 5-8, week 9-12 |
Countries
Norway
Outcome results
None listed