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Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
Hospices Civils de Lyon

Study Description
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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

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00129597     History of Changes
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:
Ketalar
NMDA
mastectomy
postoperative chronic pain
Chronic pain after mastectomy for breast cancer

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action