Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery
This multicentric, single blind study will enrol 160 women (18-75 years old) operated on
tumorectomy and adenectomy (T1, T2, T3, N0, N1, M0) for breast cancer. Patients will be
randomly assigned in a 2x2 factorial plan : Group 1 = control (n = 40) ; group 2 = ketamine
group administered during and 48 hours after a standardized anesthesia (n = 40) ; group 3 =
polyamine-free diet, 1 week and 72 hours after surgery (n = 40) ; group 4 : ketamine +
polyamine-free diet (n = 40).
The amount of morphine for the 24 first postoperative hours will be compared between each
group as well as pain score, allodynia (Von Frey filaments) and hyperalgesia (algometer).
Chronic pain occurrence (post-mastectomy pain syndrome) will be evaluated at 3 and 6 months
using adequate questionnaire ( analgesic scale). Diet observance will be controlled
preoperatively by a dosage of polyamines in circulating red cells blood.
Polyamines deprivation and ketamine ability to reduce postoperative pain will be compared
(isobolographic method). Anti-hyperalgesic properties of ketamine have already been
demonstrated in urologic, orthopaedic and abdominal surgery. In case of additive or
synergistic effect of a polyamine deprivation such a strategic could be helpful to achieve
better postoperative rehabilitation in reducing chronic pain after surgery.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
for the 24 postoperative hours
Pierre MAURETTE, Pr
DAR 3 -Pellegrin hospital-33076 Bordeaux - France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)