Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The medico-economic impact will be observed during this study.

Official Title
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A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.

Conditions
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Digestive System Surgical Procedures

Intervention / Treatment
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* Other: Polyamine Deficient Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyamine deficient diet<br>Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet | Other: Polyamine Deficient Diet<br>* Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet<br>|
| No Intervention: Control<br>Usual Diet plus two snacks | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 72 hours post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the analgesics consumption post-operatively | Measure of the analgesics consumption by the nurse during hospitalisation and by the patient with the patient book up to 15 days postsurgery | 15 days post-surgery | 
| Change in the main dimension of pain | Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI) | 6 months post-surgery | 
| Change of the recovery time of the gas transit | Evaluation of the time to recover the gas transit post-surgery (in days) | 6 months post-surgery | 
| Change of duration of urinary catheterization | Recovery of spontaneous urination post-surgery (in days) | 6 months post-surgery | 
| Change in the delay before the first postoperative lift | Time before walking post-surgery (in days) | 6 months post-surgery | 
| Change in length of hospitalisation stay and sick leave | Hospitalisation time and sick leave (in days) | 6 months post-surgery | 
| Change in neuropathic pain: Neuropathic pain scale (DN4) | Use of the Neuropathic pain scale for patients seen for their postsurgery pain or complications. The scale contains 10 questions, the range is between 0-10, 10 being the worst score. | 6 months post-surgery | 
| Change in global health status | Use of autoquestionnaire EuroQol-5 Dimension (EQ-5D) to evaluate the global health status of the patients. The scale contains two parts, the first one contains 5 items to be completed by the patients with 5 levels for each item, the worst score being 55555. The second part is an analog visual scale with a range between 0-100, 0 being the worst score. | 1 month before surgery, 1 month and 6 months post-surgery | 
| Change of the recovery ability | Evaluation of the recovery ability using the Quality of Recovery-15 Questionnaire (QoR-15) | 1 month before surgery, 1 month and 6 months post-surgery | 
| Change in the quality of life | Assessment of the patient's quality of life by using the Short-Form Health Survey 36 questionnaire (SF-36) | 1 month before surgery, 1 month and 6 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal surgery, Polyamine, Postoperative pain, Morphine, Hypersensitivity