Back to resultsEffect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Primary Purpose
Pain, Breast Cancer
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ketalar
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Ketalar, NMDA, mastectomy, postoperative chronic pain, Chronic pain after mastectomy for breast cancer
Eligibility 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
Sites / Locations
- Centre Hospitalier Lyon Sud
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00129597
Brief Title
Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Official Title
Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Breast Cancer
Keywords
Ketalar, NMDA, mastectomy, postoperative chronic pain, Chronic pain after mastectomy for breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ketalar
Primary Outcome Measure Information:
Title
To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy
Title
Pain intensity is evaluated by an appropriate questionnaire 1 and 3 months after surgery.
Secondary Outcome Measure Information:
Title
To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent PIRIOU, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre bénite
ZIP/Postal Code
69495
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
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