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Postoperative Pain and Polyamines-poor Diet (DOLAMINE) (DOLAMINE)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
poor-polyamines diet
high polyamines diet
Sponsored by
Groupe Hospitalier Diaconesses Croix Saint-Simon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Groupe hospitalier Diaconesses Croix Saint Simon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

poor-polyamines diet

high-polyamines diet

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients with a need for grade II analgesics
Overall tramadol consumption , expressed in mg.
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

Full Information

First Posted
October 29, 2015
Last Updated
February 14, 2019
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
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1. Study Identification

Unique Protocol Identification Number
NCT02592460
Brief Title
Postoperative Pain and Polyamines-poor Diet (DOLAMINE)
Acronym
DOLAMINE
Official Title
Impact on Pain of a Preoperative Polyamines-poor Diet After Orthopedic Surgery of the Foot
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
542 (Actual)

8. Arms, Groups, and Interventions

Arm Title
poor-polyamines diet
Arm Type
Experimental
Arm Title
high-polyamines diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
poor-polyamines diet
Intervention Description
Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery
Intervention Type
Other
Intervention Name(s)
high polyamines diet
Intervention Description
Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery
Primary Outcome Measure Information:
Title
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.
Description
The worst pain will be assessed retrospectively the eighth day after surgery
Time Frame
Eight days after surgery
Secondary Outcome Measure Information:
Title
Percentage of patients with a need for grade II analgesics
Time Frame
Eighth day after surgery
Title
Overall tramadol consumption , expressed in mg.
Time Frame
Eight days after surgery
Title
Worst pain, expressed in mm, measured on an visual analogic scale ranging from 0 mm to 100 mm
Description
The worst pain will be assessed retrospectively the eighth day after surgery
Time Frame
Eight days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Groupe hospitalier Diaconesses Croix Saint Simon
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

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Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

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