Efficacy of a Polyamine-free Diet Associated or Not With Ketamine on Early and Late Hyperalgesia After Breast Cancer Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- Morphine requirement
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer (T1, T2, T3, N0, N1, M0)
- •Age : 18 - 75
- •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
排除标准
- •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
研究组 & 干预措施
R+ / K+
干预措施: polyamine-free diet (Behavioral)
R+ / K+
干预措施: Ketamine or placebo (Drug)
R+ / K-
干预措施: polyamine-free diet (Behavioral)
R+ / K-
干预措施: Ketamine or placebo (Drug)
R- / K+
干预措施: Ketamine or placebo (Drug)
R- /K-
干预措施: Ketamine or placebo (Drug)
结局指标
主要结局
Morphine requirement
时间窗: for the 24 postoperative hours
次要结局
- 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)
- 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)