Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

November 2, 2016 updated by: Hopital Foch
It has been shown that N-methyl-D-aspartate (NMDA) receptor antagonists (such as ketamine) potentiate analgesic drug's efficacy. Polyamines are allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has shown antinociceptive properties. This research aims at evaluating analgesic properties of polyamine-low diet after laparoscopic cholecystectomy performed in an ambulatory setting.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Hauts de Seine
      • Paris, Hauts de Seine, France, 75020
        • Hôpital de la Croix Saint-Simon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • laparoscopic cholecystectomy
  • ambulatory surgery
  • agreeing to follow a polyamine-low diet with Polydol plus

Exclusion Criteria:

  • Pregnancy
  • Contra-indication to a non-steroidal anti-inflammatory, to tramadol
  • Intolerance to cow proteins
  • Diabetic patients
  • Poor understanding of the French language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polyamine low-diet
Polyamines depleted diet during the week before surgery : 2 cans per day of Polydol (oral alimentation without polyamines), associated to predefined menus low in polyamines
Dietary supplement: Polyamine low-diet
Other Names:
  • Poyldol plus (Nutrialys)
Active Comparator: Liberal alimentation
No specific alimentary diet
Dietary supplement: Liberal alimentation
Other Names:
  • No specific alimentary recommendation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity for the 7 days
Time Frame: 7 days
Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores measured on the day of surgery,
Time Frame: 12 hours
Pain score (numerical scale from 0 to 10) measured in mid-afternoon, resting lying down, coughing and mobilization (from lying to sitting position)
12 hours
frequency of impeded hospital discharge the day of surgery
Time Frame: 24 hours
Failure of outpatient care (i.e. the patient cannot leave the hospital the day of surgery)
24 hours
Each day pain
Time Frame: 7 days
Pain scores (numerical scale from 0 to 10) assessed daily from J1 ( after surgery) to J7 in mid afternoon , lying at rest position , coughing and mobilization (from lying to sitting position) .
7 days
Quality of life
Time Frame: 7 days
QLQC30 Questionnaire (version 3)
7 days
Residual pain
Time Frame: 30 days
Pain score (numerical scale from 0 to 10)
30 days
Blood levels of polyamine
Time Frame: 2 years
Blood samples are performed the day of surgery and at J7. The dosages will be performed when all patients will be recruited
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/68
  • 2011-A01675-36 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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