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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00181012
• Date of registration: 13/09/2005
• Prospective Registration: No
• Primary sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Public title: Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics
• Scientific title: Benefit of Lidocaine Perfusion in Cancer Related Visceral Pain Resistant to Morphinics: Efficacy Study in Adults and Children. Randomized Prospective Study With Direct Individual Benefit
• Date of first enrolment: May 2005
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00181012
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Philippe Poulain, MD

• Name: Philippe Poulain, MD

• Name: Philippe Poulain, MD
• Affiliation: Gustave Roussy, Cancer Campus, Grand Paris

Key inclusion & exclusion criteria

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



Age minimum: 6 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Pain

Intervention(s)

Drug: Lidocaine

Primary Outcome(s)

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) [Time Frame: continuous intravenous perfusion for 6 days]

Secondary Outcome(s)

To confirm the tolerance of the lidocaine

Secondary ID(s)

LIDODOULABDO

CSET 2003/1054

Source(s) of Monetary Support

Please refer to primary and secondary sponsors