Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

NCT ID: NCT00129597

Last Updated: 2007-03-12

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

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Brief Summary

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Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain is related to a sensitization of the central nervous system through N-methyl-D-asparate (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA properties after mastectomy.

Detailed Description

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Conditions

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Pain Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ketalar

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mastectomy in patients 18 to 80 years old

Exclusion Criteria

* American Society of Anesthesiology (ASA) class \>= 3
* Renal, heart or hepatic failure
* Allergy to ketalar
* Psychiatric disease
* Chronic antalgic treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Principal Investigators

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Vincent PIRIOU, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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2004.349

Identifier Type: -

Identifier Source: org_study_id

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