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NCT00129597 Clinical Trial

Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

Breast Cancer Clinical Trial

Official title:
Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00129597
Other study ID # 2004.349
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received August 10, 2005
Last updated March 9, 2007
Start date December 2004

Study information
Verified date March 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• ketalar

Locations
Country Name City State
France Centre Hospitalier Lyon Sud Pierre bénite

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy
Primary Pain intensity is evaluated by an appropriate questionnaire 1 and 3 months after surgery.
Secondary To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia
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