Status:
COMPLETED
Polyamine-free Diet to Prevent Post Surgery Hyperalgesia
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Insurance CNP foundation
Conditions:
Breast Cancer
Surgery
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonis...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Breast cancer (T1, T2, T3, N0, N1, M0)
- Age : 18 - 75
- Asa 1-3
- left or right tumorectomy with complete lymphadenectomy
- left or right complete mastectomy with complete lymphadenectomy
- complete lymphadenectomy within one week following simple tumorectomy
- informed consent signed
Exclusion
- inflammatory tumor requiring pre-operative radiotherapy
- previous history of total mastectomy or partial contralateral mastectomy
- chronic inflammatory disease treated by corticoids or NSAI
- chronic analgesic treatment
- anti-arrhythmic or anti-epileptic treatments
- morphinic treatment during the 7 days before surgery
- excessive alcohol consumption or addiction
- ketamine or neomycin contra-indication
- severe cardiovascular disease
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00304850
Start Date
March 1 2006
End Date
May 1 2009
Last Update
December 29 2009
Active Locations (5)
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1
CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne
Bordeaux, France, 33000
2
département d'anesthésie-réanimation 3, hôpital Pellegrin
Bordeaux, France, 33076
3
CLCC Alexis Vautrin
Nancy, France, 54511
4
APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation
Paris, France, 75013