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. (LIDOSP)

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase

Unknown

Phase 3

Conditions

Cancer

Pain With Neuropathic Component

Treatments

Drug: Lidocaine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02137954

2013-50

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient aged 18 years or older
Patient suffering from cancer pain refractory to standard opiates (numeric pain intensity scale NPIS >=4/10 after 24 hours of continuous intravenous morphine or oxycodone administration [SOR 2002, analgesics drugs for adults cancer nociceptive pain]), regardless of the nature of the primary cancer]
Patient suffering from cancer neuropathic or mixed pain (DNA survey score> = 4 [Bouhassira 2004])
Patient receiving palliative care as defined by French Society of Palliative and Support Care [Charte des Soins Palliatifs, 1996, Act No. 99-477 of 9 June 1999 to guarantee the right of access to palliative care] according to the definition of the World Health Organization (WHO) [World Health Organization. WHO's pain ladder. http://www.who.int/cancer/palliative/painladder/en/. Accessed December 9.2011]
Patient with histological diagnosis of cancer, locally advanced or metastatic disease
Patient without curative cancer treatment, and with or without palliative anticancer treatment
Patient hospitalized in a specific palliative care unit
Patient with an estimated survival higher than 48 hours (physician estimation) Patient providing written informed consent for participation prior to any study procedures.

Exclusion criteria

Patient with a known hypersensitivity to lidocaine
Patient with a history of porphyria, arrhythmias, disorders of atrioventricular conduction requiring permanent pacing not yet realized, uncontrolled epilepsy, uncontrolled hypertension
Patient with hematologic malignancy, abnormal renal, hepatic and cardiac functions
Patient with a altered sleepiness (Epworth scale score ≤ 16)
Patient with altered cognitive function (TELECOM scale score> 11) [Arsène 2000]
Patient not native French speaker Patient defined as vulnerable subject (minor subject, pregnant or nursing woman, subject freedom deprived)