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

Phase 3
Conditions
Cancer
Pain
Registration Number
NCT00181012
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
100
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
To determine prospectively the lidocaine efficacy in 2 types of patient populations with cancer (group A: children from 6 to 14 years old and group B: adults from 15 to 70 years old)continuous intravenous perfusion for 6 days
Secondary Outcome Measures
NameTimeMethod
To confirm the tolerance of the lidocaine

Trial Locations

Locations (1)

Institut Gustave-Roussy

🇫🇷

Villejuif, France

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