Overview

This trial is active, not recruiting.

Conditions pain, breast cancer
Treatment ketalar
Phase phase 4
Sponsor Hospices Civils de Lyon
Start date December 2004
Trial size 40 participants
Trial identifier NCT00129597, 2004.349

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Measure
To evaluate the effect of perioperative ketalar on pain intensity 3 months after a mastectomy
time frame:
Pain intensity is evaluated by an appropriate questionnaire 1 and 3 months after surgery.
time frame:

Secondary Outcomes

Measure
To evaluate the incidence of chronic pain after mastectomy, the impact on life quality, and the area of hyperalgesia
time frame:

Eligibility Criteria

Female participants from 18 years up to 80 years old.

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

Additional Information

Official title Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy
Principal investigator Vincent PIRIOU, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.