Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics

Gustave Roussy

Status and phase: Unknown; Phase 3

Conditions: Cancer; Pain

Treatments: Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00181012

CSET 2003/1054

LIDODOULABDO

Details and patient eligibility

About

This study will evaluate the benefit of lidocaine perfusion in cancer related visceral pain resistant to morphinics. It is an efficacy study in adults and children and a randomized prospective study.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from cancer of any type, at any stage, hospitalized at the Institut Gustave Roussy
• Aged from 6 to 14 years old (group A) and from 15 to 70 years old (adults)
• Presenting visceral pain due to neurotoxic chemotherapy, due to the tumoral mass or to peritoneal carcinosis
• Pain resistant to morphinic treatment

Exclusion criteria

• Cardiac troubles, clinical cardiac insufficiency, or history of myocardial infarction (MI) of less than 3 months
• Neurological: non-controlled epilepsy, encephalopathy, or dementia
• Severe hepatic insufficiency
• Severe renal insufficiency
• Respiratory insufficiency
• Patients having surgery or in postoperative period
• Known deficit in G6PD, alanine exposure, or sulphamide treatment
• Porphyria
• Weight > 80 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind