A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 278
- 试验地点
- 8
- 主要终点
- To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group
研究概览
简要总结
The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.
详细描述
Morphine derivatives are known to be a major cause of postoperative ileus and also operative hyperalgesia. Operative hyperalgesia corresponds to an increase in morphine needs postoperatively which is proportional to the morphine dose necessary during the surgery. This effect is due to two mechanisms: opioids tolerance and induced hypersensitivity.
N-methyl-D-aspartate receptors (R-NMDA) play a key role in this induced hypersensitivity. Polyamines, organic compounds with several amines functions, are known R-NMDA agonists. They increase the phosphorylation of the tyrosine group within the NR2B subunit responsible for the inflammatory hyperalgesia.
Limiting the binding of polyamines to the R-NMDA seems an easy, safe and efficient way to limit the hypersensitivity induced post-operatively.
Most of the polyamines in the human body come from food. One study listed food regarding their polyamines content and allowed to check the safety of a polyamine deficient diet. Such a well-followed diet would allow to reduce by 20 the polyamines quantity present in the body.
The aim of this study is to evaluate whether a deficient polyamine diet introduced 7 days before and continued up to 7 days after an abdominal surgery requiring the use of morphine post-operatively reduces the post-operative pain, the consumption of analgesics (morphine) post-operatively and improve the recovery ability. Abdominals surgeries concerned will be the eventration cure and digestive continuity.
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
- Single (Care Provider)
盲法说明
The anesthetist is blinded to the arm of attribution
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
- •Adult (>18 years)
- •Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity
- •Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids
- •Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications)
- •Written informed consent form obtained from the patient
- •Affiliated to the social security
排除标准
- •Pregnant women
- •Minor, adult under guardianship or benefiting from a legal protection
- •Oncological surgery
- •Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)
- •Drug addicts patients, or under opiate dependency
- •Chronic pain patients (pain over 3 months)
- •Patients in nursing home or convalescence home (diet non possible in institution)
- •Planned hospitalisation before the intervention (during the 7 days before the surgery)
- •Severe undernutrition defined by the HAS criteria (weight loss > 10% in 1 month and/or > 15% in 6 months, albumin at inclusion <15g/l)
- •Patient refusing the possibility to change his eating habits
- •Oral feeding impossible preoperatively
- •Patient not able to express himself on their pain (silent, …)
- •Decompensated psychiatric pathologies (severe depression syndrome,…)
- •Patient unable to understand the protocol and/or to give his informed consent
研究组 & 干预措施
Polyamine deficient diet
Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet
干预措施: Polyamine Deficient Diet (Other)
Control
Usual Diet plus two snacks
结局指标
主要结局
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group
时间窗: 72 hours post-surgery
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group measured every 6 hours in resting position, upon return from the operative room
次要结局
- Change in the main dimension of pain(6 months post-surgery)
- Change in global health status(1 month before surgery, 1 month and 6 months post-surgery)
- Change in the analgesics consumption post-operatively(15 days post-surgery)
- Change of the recovery time of the gas transit(6 months post-surgery)
- Change in neuropathic pain: Neuropathic pain scale (DN4)(6 months post-surgery)
- Change of duration of urinary catheterization(6 months post-surgery)
- Change in the delay before the first postoperative lift(6 months post-surgery)
- Change in length of hospitalisation stay and sick leave(6 months post-surgery)
- Change of the recovery ability(1 month before surgery, 1 month and 6 months post-surgery)
- Change in the quality of life(1 month before surgery, 1 month and 6 months post-surgery)