Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test if rufinamide has an effect on chronic neuropathic pain in patients with a post thoracotomy pain syndrome.

Detailed Description
-----------------
Patients with chronic neuropathic pain after thoracic surgery will be evaluated and treated with oxycodone. Patients with a stable analgesic regimen, not reaching a good pain relief will be randomized to receive Rufinamide (Inovelon)vs. Placebo as an ad-on treatment to oxycodone. Neurophysiological and clinical data will be monitored.

Official Title
-----------------
Effect of Rufinamide on Chronic Postthoracotomy Pain Syndrome. A Prospective, Randomized, Double-blind, Placebo Controlled, Monocenter Study.

Conditions
-----------------
Peripheral Nerve Injuries, Pain

Intervention / Treatment
-----------------
* Drug: Rufinamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria, Run-In Phase: Age: 18-75 years Weight: 50 - 100kg Height: 155 - 195cm Sufficient command of German language Patient after thoracotomy Pain duration of more than 6 month. Diagnosis of Neuropathic Pain (DN4 questionnaire) Average baseline mean last week pain intensity =5 on NRS (numerical rating scale) Signed and dated informed consent Inclusion criteria, Treatment Phase: Stable analgesic regimen for at least 7 days prior to randomisation Patients not reaching a NRS = 3 (numeric rating scale) with the baseline individually dose adjusted treatment (oxycodone). Exclusion criteria: Contraindications to the class of drugs under study, e.g. (rufinamide, oxycodone) known hypersensitivity or allergy this class of drugs Hypersensitivity to triazole derivates - antifungal drugs including: fluconazole (e.g. Diflucan®), posaconazole (Noxafil®), itraconazole (Sporanox®), voriconazole (Vfend®) Lactose intolerance, galactosemia or galactokinase deficiency, glucose-galactose malabsorption Use of topical analgesics, or nerve block of the affected or adjacent dermatomes (less than to 2 weeks prior to the therapy onset visit or during the study period) Women who are pregnant or breast feeding; intention to become pregnant during the course of the study, lack of safe contraception, defined as: female subjects of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not willing or able to use any other second (additional) considered sufficiently reliable by the investigator in individual cases. Female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, severe cardiovascular disease, etc) Creatinine clearance = 30 ml/min (estimated from serum creatinine using the Cockcroft - Gault formula) were excluded Known drug (opiate or other) or alcohol abuse Contraindication to the use of oxycodone Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject Participation in another study with investigational drugs within the 30 days preceding and during the present study Enrollment of the investigators, his/her family members, employees and other dependent persons Known neurological disease with peripheral manifestations including neuropathy associated with disease such as diabetes Known sensory changes from other medical conditions (e.g. infections affecting the investigation areas, post-herpetic neuralgia) Epilepsy Abnormal electrocardiogram (especially Familial Short QT syndrome) Patient having another pain condition with greater pain intensity Repeated thoracic surgeries Pneumonectomy or chest wall resection Bilateral thoracic surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rufinamide<br>- oral Rufinamide administration as ad-on to Oxycodone | Drug: Rufinamide<br>* 2x200mg up to max 2x800mg a day Titration over 20days<br>* Other names: Inovelon;|
| Placebo Comparator: Manitol<br>- oral Placebo administration - as ad-on to Oxycodone | Drug: Rufinamide<br>* 2x200mg up to max 2x800mg a day Titration over 20days<br>* Other names: Inovelon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area of punctuate hyperalgesia immediately after topical capsaicin. | The primary variable to test is the area of punctuate hyperalgesia after topical capsaicin application in patients treated with rufinamide versus placebo. | 2h after capsaicin removal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic Surgical Procedures