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Real life use of lidocaine patch 5% in peripheral neuropathic pain: an institutional approval study aimed at increasing medication access in public health services

Grant number: 20/04768-4
Support type:Scholarships in Brazil - Scientific Initiation
Effective date (Start): September 01, 2020
Effective date (End): August 31, 2021
Field of knowledge:Health Sciences - Medicine
Principal researcher:Daniel Ciampi Araujo de Andrade
Grantee:Carolina Campos dos Santos
Home Institution: Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil

Abstract

This is a prospective open study with a single arm based on the measured results of 60 patients (with the possibility of expanding the sample number) using the validated Brief Pain Inventory (BPI) questionnaires; Douleur Neuropathique-4 Question (DN-4); Neuropathic Pain Symptom Inventory (NPSI); Euro-QoL (EQ5D); Insomnia Severity Index (ISI); Multidimensional Fatigue Symptom Inventory Short Form (MFSISF). The study's hypothesis is that lidocaine plaster administered as an addition to the usual pharmacological treatment for painful polyneuropathies (selective serotonin or norepinephrine reuptake inhibitors, antidepressants or tricyclics) reduces the intensity of pain and alleviates the negative impact of pain on quality of these patients. Method: the included patients will be divided into two groups: spontaneous and continuous pain and non-spontaneous and non-continuous pain. All will receive a lidocaine patch 5%, the dose of which will be increased to the maximum tolerated by the patient within 3 weeks. The maximum fixed tolerated dose will be used for 6 months. All patients will be followed for a further 6 months after the use of the patch is stopped. Primary Objective: evaluate the analgesic effect of administration of the lidocaine patch 5% as an adjunct to antidepressants (tricyclics or selective serotonin and norepinephrine reuptake inhibitors) and opioids in peripheral neuropathic pain, using the Visual Analogue Scale in responders to the week-long treatment (defined by a 30% reduction in baseline pain intensity) Secondary Objective: compare pain interference in activities of daily living, quality of life and with the analgesic medication in use; assess the safety profile of the treatment; assess the effect of treatment on different painful neuropathic syndromes measured by the Neuropathic Pain Symptom Inventory (NPSI); assess the impact on pharmacoeconomics with the use of lidocaine in patients with chronic neuropathic pain in the "real life" scenario.