Impact on Pain of a Preoperative Polyamines-poor Diet After Orthopedic Surgery of the Foot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 542
- 试验地点
- 2
- 主要终点
- Percentage of patients whose worst pain, as measured on an visual analogic scale ranging from 0 mm to 100 mm, was at least once rated as 30 mm or more.
研究概览
简要总结
Animal studies have shown that the level of pain sensitivity is highly dependent on the amount of polyamines in food. This fundamental observation of a nutritional approach to pain led the authors to develop diets completely depleted in polyamines whose anti-nociceptive properties have been confirmed in animals.
Postoperative pain after foot surgery are currently fairly well controlled but at the cost of a high consumption of grade II analgesics which is associated with a high rate of side effects (nausea, vomiting ...). The investigators' hypothesis is that a diet low in polyamines may have an additive effect on pain control and reduce the consumption of level 2 analgesics.
The objective of this study is to show the efficacy of a polyamines-poor diet on postoperative pain in ambulatory surgery of the foot.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •foot ambulatory orthopedic surgery
- •surgery scheduled at least 10 days after the inclusion consultation
排除标准
- •other diet susceptible to interfere with the poor or high-polyamines diets (e.g. diabetic patients)
- •contraindication to tramadol or to NSAIDs
- •pregnant or breastfeeding woman
- •patient under legal protection
- •patient's opposition to participate in the study
- •poor understanding of French
- •absence of affiliation to social security
- •participation to another study
研究组 & 干预措施
poor-polyamines diet
干预措施: poor-polyamines diet (Other)
high-polyamines diet
干预措施: high polyamines diet (Other)
结局指标
主要结局
Percentage of patients whose worst pain, as measured on an visual analogic scale ranging from 0 mm to 100 mm, was at least once rated as 30 mm or more.
时间窗: Eight days after surgery
The worst pain will be assessed retrospectively the eighth day after surgery
次要结局
- Overall tramadol consumption , expressed in mg.(Eight days after surgery)
- Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm(Eight days after surgery)
- Percentage of patients with a need for grade II analgesics(Eighth day after surgery)