Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

This study is ongoing, but not recruiting participants.

Sponsored by:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00129597

Purpose

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.

Condition	Intervention	Phase
Pain Breast Cancer	Drug: ketalar	Phase IV

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

Drug Information available for: Ketamine Ketamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy
Pain intensity is evaluated by an appropriate questionnaire 1 and 3 months after surgery.

Secondary Outcome Measures:

To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia

Estimated Enrollment:	40
Study Start Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129597

Locations

France
Centre Hospitalier Lyon Sud
Pierre bénite, France, 69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Vincent PIRIOU, MD

Hospices Civils de Lyon

More Information

Study ID Numbers:	2004.349
Study First Received:	August 10, 2005
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00129597
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

Ketalar
NMDA
mastectomy
postoperative chronic pain
Chronic pain after mastectomy for breast cancer

Study placed in the following topic categories:

Excitatory Amino Acids
Skin Diseases
Ketamine

Breast Neoplasms
Pain
Breast Diseases

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 15, 2009