Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
March 9, 2007 updated by: Hospices Civils de Lyon
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.
Study Overview
Study Type
Interventional
Enrollment
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pierre bénite, France, 69495
- Centre Hospitalier LYON SUD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy
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Pain intensity is evaluated by an appropriate questionnaire 1 and 3 months after surgery.
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Secondary Outcome Measures
Outcome Measure |
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To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vincent PIRIOU, MD, Hospices Civils de Lyon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Study Registration Dates
First Submitted
August 10, 2005
First Submitted That Met QC Criteria
August 10, 2005
First Posted (Estimate)
August 12, 2005
Study Record Updates
Last Update Posted (Estimate)
March 12, 2007
Last Update Submitted That Met QC Criteria
March 9, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Chronic Pain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- 2004.349
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.