Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Phase 4
- Conditions
- PainBreast Cancer
- Registration Number
- NCT00129597
- Lead Sponsor
- Hospices Civils de Lyon
- 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 available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 40
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia
Trial Locations
- Locations (1)
Centre Hospitalier Lyon Sud
🇫🇷Pierre bénite, France
Centre Hospitalier Lyon Sud🇫🇷Pierre bénite, France