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Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

NCT02592460 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2019-02-15

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Pain

Interventions

OTHER

poor-polyamines diet

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

OTHER

high polyamines diet

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

Sponsors & Collaborators

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02592460 on ClinicalTrials.gov