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Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129597
Recruitment Status : Unknown
Verified March 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : August 12, 2005
Last Update Posted : March 12, 2007
Information provided by:
Hospices Civils de Lyon

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Breast Cancer Drug: ketalar Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Study Start Date : December 2004

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129597

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Centre Hospitalier Lyon Sud
Pierre bénite, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Vincent PIRIOU, MD Hospices Civils de Lyon
Layout table for additonal information Identifier: NCT00129597    
Other Study ID Numbers: 2004.349
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: March 12, 2007
Last Verified: March 2007
Keywords provided by Hospices Civils de Lyon:
postoperative chronic pain
Chronic pain after mastectomy for breast cancer
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action