Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

Phase 4

• Conditions: Pain; Breast 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

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-08-10
• Study First Submitted QC: 2005-08-10
• Study First Posted: 2005-08-12
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-09
• Last Update Posted: 2007-03-12

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