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

NCT ID: NCT00181012

Last Updated: 2007-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Brief Summary

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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

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Conditions

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Cancer Pain

Keywords

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Cancer Related Visceral Pain Resistant to Morphinics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lidocaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Principal Investigators

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Philippe Poulain, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave-Roussy

Villejuif, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe Poulain, MD

Role: CONTACT

Phone: 33 1 42 11 40 53

Email: [email protected]

Facility Contacts

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Philippe Poulain, MD

Role: primary

Other Identifiers

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CSET 2003/1054

Identifier Type: -

Identifier Source: secondary_id

LIDODOULABDO

Identifier Type: -

Identifier Source: org_study_id