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NCT Number: NCT02592460

Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe hospitalier Diaconesses Croix Saint Simon

Paris, Île-de-France Region, 75020, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

poor-polyamines diet

Other

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

high polyamines diet

Other

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

Primary outcomes

  1. 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.

    Time frame: Eight days after surgery

    The worst pain will be assessed retrospectively the eighth day after surgery

Secondary outcomes

  1. Percentage of patients with a need for grade II analgesics

    Time frame: Eighth day after surgery

  2. Overall tramadol consumption , expressed in mg.

    Time frame: Eight days after surgery

  3. Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm

    Time frame: Eight days after surgery

    The worst pain will be assessed retrospectively the eighth day after surgery

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Official study title

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

Acronym: DOLAMINE

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2015
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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