Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

542 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-07-31

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.

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Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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poor-polyamines diet

Group Type EXPERIMENTAL

poor-polyamines diet

Intervention Type OTHER

Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery

high-polyamines diet

Group Type ACTIVE_COMPARATOR

high polyamines diet

Intervention Type OTHER

Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery

Interventions

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poor-polyamines diet

Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery

Intervention Type OTHER

high polyamines diet

Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No