Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
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

Tracking Information
First Submitted Date  ICMJE August 10, 2005
First Posted Date  ICMJE August 12, 2005
Last Update Posted Date March 12, 2007
Study Start Date  ICMJE December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
To evaluate the effect of peroperative ketalar on pain intensity 3 month after a mastectomy. Pain intensity is evaluated by an appropriate questionnaire 1 and 3, months after surgery.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia
Original Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2005)
Secondary outcome is to evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Official Title  ICMJE Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Breast Cancer
Intervention  ICMJE Drug: ketalar
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: August 10, 2005)
40
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00129597
Other Study ID Numbers  ICMJE 2004.349
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hospices Civils de Lyon
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vincent PIRIOU, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP