Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

Study Overview
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Brief Summary
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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.

Official Title
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Impact on Pain of a Preoperative Polyamines-poor Diet After Orthopedic Surgery of the Foot

Conditions
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Postoperative Pain

Intervention / Treatment
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* Other: poor-polyamines diet
* Other: high polyamines diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: foot ambulatory orthopedic surgery surgery scheduled at least 10 days after the inclusion consultation Exclusion Criteria: 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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: poor-polyamines diet<br> | Other: poor-polyamines diet<br>* Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery<br>|
| Active Comparator: high-polyamines diet<br> | Other: high polyamines diet<br>* Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The worst pain will be assessed retrospectively the eighth day after surgery | Eight days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a need for grade II analgesics |  | Eighth day after surgery | 
| 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 | The worst pain will be assessed retrospectively the eighth day after surgery | Eight days after surgery |