Lidocaine 5% Medicated Plaster in Chronic Neuropathic Postoperative Pain
|ClinicalTrials.gov Identifier: NCT01155986|
Recruitment Status : Terminated (Trial was stopped due to difficult enrolment)
First Posted : July 2, 2010
Last Update Posted : October 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Chronic Pain Neuropathic Pain Postoperative Pain||Drug: Lidocaine 5% medicated plaster Drug: Placebo topical plaster||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Lidocaine 5% Medicated Plaster for the Topical Treatment of Localized Chronic Postoperative Neuropathic Pain.|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Placebo Comparator: Placebo Plaster
Drug: Placebo topical plaster
Topical hydrogel plaster
|Active Comparator: Lidocaine Plaster||
Drug: Lidocaine 5% medicated plaster
Topical hydrogel plaster (700mg lidocaine)
Other Name: Versatis(R)
- Analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic postoperative neuropathic pain [ Time Frame: daily assessments over 4 weeks ]
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).
- Effect of lidocaine 5% medicated plaster on quality of life [ Time Frame: 4 weeks ]EuroQol-5 Dimension Scores
- Neuropathic Pain Symptoms [ Time Frame: 4 weeks ]Changes in severity of various neuropathic pain symptoms, e.g. allodynia, will be recorded by the Neuropathic Pain Symptom Inventory (NPSI) and neurological examinations
- Incidence of adverse events [ Time Frame: up to 44 days ]Measurement of adverse events including those derived from laboratory data or vital signs measurements.
- Hospital Anxiety and Depression Scale [ Time Frame: 4 weeks ]
- Subject's Global Impression of Change [ Time Frame: 4 weeks ]
- Treatment Satisfaction Questionnaire for Medication [ Time Frame: 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155986
|Principal Investigator:||Jean Bruxelle||Fondation Ophtalmologique Adolphe de Rotschild, Service de Neurochirurgie, CEntre d'Evaluation et de Traitement de la Douleur|