Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy

Condition(s) targeted: Pain; Breast Cancer

Intervention: ketalar (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Vincent PIRIOU, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon

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.

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

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

Primary outcome:

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.

Criteria:

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

Centre Hospitalier Lyon Sud, Pierre bénite 69495, France

Starting date: December 2004
Last updated: March 9, 2007