Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.

Detailed Description
-----------------
Some patients who undergo different types of surgery develop distressing and long-lasting pain. This pain is often characterized by signs such as: allodynia (a pain due to a stimulus which does not normally provoke pain), dysesthesia (unpleasant, abnormal sense of touch). Patients describe symptoms of burning or electrical type sensation. In some cases this type of chronic pain can still be present after 3 months or more following surgery.This clinical trial will assess the efficacy and safety profile of lidocaine 5% medicated plaster in comparison to placebo plaster in patients. This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), placebo-controlled, parallel-group, multicenter trial to evaluate topical analgesic treatment of chronic neuropathic pain after surgery. The trial will include a screening phase and a treatment phase, during which subjects will be treated with either 5% lidocaine medicated plaster, or a placebo plaster pain intensity will be assessed on a daily basis. Subsequently there will be a follow-up phase. Pain intensity numeric rating scale (PI) will be collected via the numeric rating scale and averaged. Safety evaluations include monitoring of adverse events, physical examinations, and clinical laboratory tests.

Official Title
-----------------
Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.

Conditions
-----------------
Pain, Chronic Pain, Neuropathic Pain, Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Lidocaine 5% medicated plaster
* Drug: Placebo topical plaster


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects with >= 18 years of age Intact skin in the area of topical treatment Patients suffering from moderate to severe ( 5 or more points on an 11 point Numerical Rating Scale where 10 is the worst possible pain, and 0 indicates no pain) chronic daily postoperative neuropathic pain for the past 6 to 24 months. Patients should have symptoms for example allodynia (a pain due to a stimulus which does not normally provoke pain); and or dysesthesia (unpleasant, abnormal sense of touch). Exclusion Criteria: Contraindications to lidocaine 5% medicated plaster, or paracetamol Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 3 years. Evidence or history (during the past 3 years) of epilepsy, neurotic personality, psychiatric illness, or suicide risk. Pregnant or breastfeeding women Women of childbearing potential who are sexually active without satisfactory contraception for at least 28 days prior to enrollment, during the trial, and until 28 days after the follow-up visit. Severe renal, hepatic or heart disorder. Surgery in the past 3 months before screening. Anticipated need for surgery during the trial, requiring at least regional or general anesthesia. Pending litigation due to chronic pain or disability. Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial. Presence of other severe pain that could confound the assessment or self- evaluation of the localized postoperative neuropathic pain. For patients with chronic postoperative neuropathic pain related to a surgery due to tumors: suspected residual tumor or metastases, chemotherapy or radiotherapy for treatment of tumor(s). Total anesthesia in the area of localized chronic pain

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Plaster<br>Active Comparator | Drug: Placebo topical plaster<br>* Topical hydrogel plaster<br>|
| Active Comparator: Lidocaine Plaster<br> | Drug: Lidocaine 5% medicated plaster<br>* Topical hydrogel plaster (700mg lidocaine)<br>* Other names: Versatis(R);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain | Participants will be selected based on their medical history and clinical examination. A questionnaire called DN4, which stands for 'douleur neuropathique 4' (i.e., '4 questions neuropathic pain will be used to identify subjects with neuropathic pain.) Pain will be assessed on and 11-point numerical rating scale (0 = no pain, 10 = worst pain imaginable). Efficacy of the treatment (i.e., reduction of neuropathic pain) will be evaluated with the 11-point numeric rating scale (NRS). | daily assessments over 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of lidocaine 5% medicated plaster on quality of life | EuroQol-5 Dimension Scores | 4 weeks | 
| Neuropathic Pain Symptoms | Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations | 4 weeks | 
| Incidence of adverse events | Measurement of adverse events including those derived from laboratory data or vital signs measurements. | up to 44 days | 
| Hospital Anxiety and Depression Scale |  | 4 weeks | 
| Subject's Global Impression of Change |  | 4 weeks | 
| Treatment Satisfaction Questionnaire for Medication |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
analgesic, analgesics, pain, chronic pain, localized pain, focal pain, neuropathic pain, postoperative pain, topical analgesia