Clinical Trials Directory

Trials / Completed

CompletedNCT02592460

Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
542 (actual)
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERpoor-polyamines dietPatients in this will receive a poor-polyamines diet during a week before and a week after foot surgery
OTHERhigh polyamines dietPatients in this will receive a high-polyamines diet during a week before and a week after foot surgery

Timeline

Start date
2014-12-01
Primary completion
2017-07-01
Completion
2017-07-01
First posted
2015-10-30
Last updated
2019-02-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02592460. Inclusion in this directory is not an endorsement.