CompletedPhase 2ketamine

Polyamine-free Diet to Prevent Post Surgery Hyperalgesia

Sponsored by University Hospital, Bordeaux

NCT ID
NCT00304850
Target Enrollment
160 participants
Start Date
2006-03
Est. Completion
2009-05

About This Study

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 antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine

Conditions Studied

Breast CancerSurgery

Interventions

  • polyamine-free diet
  • Ketamine or placebo

Eligibility

Sex:FEMALE
Age:18 Years - 75 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Study Locations (5)

CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne
Bordeaux, France
département d'anesthésie-réanimation 3, hôpital Pellegrin
Bordeaux, France
CLCC Alexis Vautrin
Nancy, France
APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation
Paris, France
CLCC Réné Huguenin de Saint Cloud
Saint-Cloud, France

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source