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| ID | Type | Description | Link |
|---|---|---|---|
| 2002-004 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Insurance CNP foundation | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R+ / K+ | Experimental |
| |
| R+ / K- | Experimental |
| |
| R- / K+ | Experimental |
| |
| R- /K- | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| polyamine-free diet | Behavioral | Polyamine-free diet in the 7 days befor surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine requirement | for the 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity for the 4 days (and possibly at 7th day if the patient is still hospitalized) after surgery | 4 days | |
| Allodynia measurements | inclusion, 1, 2, 4 and 7 ddays after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre MAURETTE, Pr | DAR 3 -Pellegrin hospital-33076 Bordeaux - France | Principal Investigator |
| Genevieve CHENE, Pr | University hospital - 33076 Bordeaux - France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLCC-Institut Bergonie, service d'anesthésie réanimation, 229 cours de l'Argonne | Bordeaux | 33000 | France | |||
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Ketamine or placebo | Drug | Peroperative and post operative (48h) ketamine injection |
|
| Hyperesthesia measurements |
| inclusion, 1, 2, 4 and 7 ddays after surgery |
| Chronic pain incidence | 3 and 6 months |
| Late allodynia and/or hyperesthesia | 6 months |
| safety of treatment | Along each patient folow-up |
| département d'anesthésie-réanimation 3, hôpital Pellegrin |
| Bordeaux |
| 33076 |
| France |
| CLCC Alexis Vautrin | Nancy | 54511 | France |
| APHParis Hôpital Pitié Salpétrière - Dépt. d'anesthésie réanimation | Paris | 75013 | France |
| CLCC Réné Huguenin de Saint Cloud | Saint-Cloud | 92210 | France |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |