NCT02083003终止4 期
Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Hopital Foch
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Pain intensity for the 7 days
研究概览
简要总结
It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine) potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic cholecystectomy performed in an ambulatory setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •laparoscopic cholecystectomy
- •ambulatory surgery
- •agreeing to follow a polyamine-low diet with Polydol plus
排除标准
- •Pregnancy
- •Contra-indication to a non-steroidal anti-inflammatory, to tramadol
- •Intolerance to cow proteins
- •Diabetic patients
- •Poor understanding of the French language.
结局指标
主要结局
Pain intensity for the 7 days
时间窗: 7 days
Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients
次要结局
- Pain scores measured on the day of surgery,(12 hours)
- Each day pain(7 days)
- Blood levels of polyamine(2 years)
- frequency of impeded hospital discharge the day of surgery(24 hours)
- Quality of life(7 days)
- Residual pain(30 days)
研究者
研究点 (2)
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