Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Other: high polyamines diet; Other: poor-polyamines diet

• Registration Number: NCT02592460
• Lead Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 542

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high-polyamines diet	high polyamines diet	-
poor-polyamines diet	poor-polyamines diet	-

Primary Outcome Measures

Name	Time	Method
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.	Eight days after surgery	The worst pain will be assessed retrospectively the eighth day after surgery

Secondary Outcome Measures

Name	Time	Method
Overall tramadol consumption , expressed in mg.	Eight days after surgery
Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm	Eight days after surgery	The worst pain will be assessed retrospectively the eighth day after surgery
Percentage of patients with a need for grade II analgesics	Eighth day after surgery

Trial Locations

Locations (1)

Groupe hospitalier Diaconesses Croix Saint Simon; 🇫🇷 Paris, Ile De France, France