Polyamine-free Diet to Prevent Post Surgery Hyperalgesia
Ключавыя словы
Рэферат
Апісанне
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.
Даты
| Апошняя праверка: | 11/30/2009 |
| Упершыню прадстаўлена: | 03/16/2006 |
| Меркаваная колькасць заявак прадстаўлена: | 03/16/2006 |
| Першае паведамленне: | 03/19/2006 |
| Апошняе абнаўленне адпраўлена: | 12/23/2009 |
| Апошняе абнаўленне апублікавана: | 12/28/2009 |
| Фактычная дата пачатку даследавання: | 02/28/2006 |
| Разліковая дата першаснага завяршэння: | 03/31/2009 |
| Разліковая дата завяршэння даследавання: | 04/30/2009 |
Стан альбо хвароба
Ўмяшанне / лячэнне
Behavioral: polyamine-free diet
Drug: Ketamine or placebo
Фаза
Групы ўзбраенняў
| Рука | Ўмяшанне / лячэнне |
|---|---|
| Experimental: R+ / K+ | |
| Experimental: R+ / K- | |
| Experimental: R- / K+ | |
| Placebo Comparator: R- /K- |
Крытэрыі прыдатнасці
| Узрост, які мае права на вучобу | 18 Years Каб 18 Years |
| Пол, прыдатны для навучання | Female |
| Прымае здаровых валанцёраў | Так |
| Крытэрыі | 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 |
Вынік
Першасныя вынікі
1. Morphine requirement [for the 24 postoperative hours]
Меры другаснага выніку
1. Pain intensity for the 4 days (and possibly at 7th day if the patient is still hospitalized) after surgery [4 days]
2. Allodynia measurements [inclusion, 1, 2, 4 and 7 ddays after surgery]
3. Hyperesthesia measurements [inclusion, 1, 2, 4 and 7 ddays after surgery]
4. Chronic pain incidence [3 and 6 months]
5. Late allodynia and/or hyperesthesia [6 months]
6. safety of treatment [Along each patient folow-up]
