Postoperative Pain and Polyamines-poor Diet (DOLAMINE)

NCT02592460 | Completed

• 1 other identifier: WGF_2014-2
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

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.

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

  Eight days after surgery

Secondary Outcomes (3)

• Percentage of patients with a need for grade II analgesics

  Eighth day after surgery

• 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

Study Arms (2)

poor-polyamines diet

EXPERIMENTAL

Other: poor-polyamines diet

high-polyamines diet

ACTIVE COMPARATOR

Other: high polyamines diet

Interventions

poor-polyamines diet OTHER

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

poor-polyamines diet

high polyamines diet OTHER

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

high-polyamines diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• foot ambulatory orthopedic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe hospitalier Diaconesses Croix Saint Simon

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

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: February 15, 2019

Record last verified: 2017-10

Locations

FR (1)