Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

Postoperative Pain Clinical Trial

— DOLAMINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592460
• Other study ID #: WGF_2014-2
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
France	Groupe hospitalier Diaconesses Croix Saint Simon	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon

Country where clinical trial is conducted

France, 

Outcome

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