ClinicalTrials.Veeva

Menu

Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

G

Groupe Hospitalier Diaconesses Croix Saint-Simon

Status

Completed

Conditions

Postoperative Pain

Treatments

Other: poor-polyamines diet
Other: high polyamines diet

Study type

Interventional

Funder types

Other

Identifiers

NCT02592460
WGF_2014-2

Details and patient eligibility

About

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.

Enrollment

542 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

542 participants in 2 patient groups

poor-polyamines diet
Experimental group
Treatment:
Other: poor-polyamines diet
high-polyamines diet
Active Comparator group
Treatment:
Other: high polyamines diet

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems