Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Lidocaine

Analgesics, Opioid

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Lidocaine. Initial dose IV will be 5 mg/kg per day during the first 24 hours the 8 mg/kg per day

Placebo

Sebastien SALAS, MD

Sebastien Salas, MD

sebastien salas, MD

This is a multicenter, prospective, randomized, placebo-controlled, double-blind, two-parallel groups study comparing lidocaine (experimental group) to placebo (control group). The study protocol was elaborated using the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) Statement.

Efficacy of Lidocaine Versus Placebo in Palliative Care Patients With Opioid-refractory Cancer Pain With Neuropathic Component: a Multicenter, Prospective, Double-blind Randomized Placebo-controlled Study.

raw values of pain levels (NPIS) at each evaluation time, percentage of reduction between the initial level of pain and other evaluation times

The tolerance to the treatment (lidocaine) will be assessed during the first 48 hours following the treatment administration. Adverse events will be cautiously collected (intensity and discomfort): i) lidocaine: arrhythmia, blurred vision, headache, malaise, tremors, metallic taste, nausea/vomiting, perioral numbness and tingling, sedation, and tinnitus.

Analgesic efficacy will be assessed from several endpoints. The primary endpoint will be defined as the change of pain level between baseline (T0) and 40 minutes (T1) after baseline. The pain level will be assessed using a self-administered numeric pain intensity scale (NPIS), ranged from 0 (no pain) to 10 (worst pain possible). A minimal 30% decrease of pain level between baseline and T1 will define the success, and other cases will define the failure of the treatment.

the intensity of the pain neuropathic component using the Neuropathic Pain Symptom Inventory (NPSI) at T4, T5, and T6 {Bouhassira, 2004 #9}; the NPSI is a 12-item self-administered questionnaire describing the intensity of the symptoms associated with pain neuropathic

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Lidocaine Versus Placebo in Palliative Care Patients With Opioid-refractory Cancer Pain With Neuropathic Component: a Multicenter, Prospective, Double-blind Randomized Placebo-controlled Study.	NCT02137954	Cancer Pain With Neuro...	Lidocaine Placebo	18 Years - 90 Years	Assistance Publique Hopitaux De Marseille
Efficacy of Lidocaine Versus Placebo in Palliative Care Patients With Opioid-refractory Cancer Pain With Neuropathic Component: a Multicenter, Prospective, Double-blind Randomized Placebo-controlled Study.	NCT02137954	Cancer Pain With Neuro...	Lidocaine Placebo	18 Years - 90 Years	Assistance Publique Hopitaux De Marseille

Spots Global Cancer Trial Database for pain with neuropathic component