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Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

Sponsor
Hopital Foch (Other)
Overall Status
Terminated
CT.gov ID
NCT02083003
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
24
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Polyamine low-diet
  • Dietary Supplement: Liberal alimentation
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jan 1, 2015
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain intensity for the 7 days [7 days]

      Pain intensity is evaluated by the number of tablets of Tramadol taken by the patients

    Secondary Outcome Measures

    1. Pain scores measured on the day of surgery, [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)

    2. frequency of impeded hospital discharge the day of surgery [24 hours]

      Failure of outpatient care (i.e. the patient cannot leave the hospital the day of surgery)

    3. Each day pain [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) .

    4. Quality of life [7 days]

      QLQC30 Questionnaire (version 3)

    5. Residual pain [30 days]

      Pain score (numerical scale from 0 to 10)

    6. Blood levels of polyamine [2 years]

      Blood samples are performed the day of surgery and at J7. The dosages will be performed when all patients will be recruited

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 76 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital de la Croix Saint-Simon Paris Hauts de Seine France 75020

    Sponsors and Collaborators

    • Hopital Foch

    Investigators

    • Study Chair: Marc Fischler, MD, Hopital Foch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hopital Foch
    ClinicalTrials.gov Identifier:
    NCT02083003
    Other Study ID Numbers:
    • 2011/68
    • 2011-A01675-36
    First Posted:
    Mar 11, 2014
    Last Update Posted:
    Nov 3, 2016
    Last Verified:
    Nov 1, 2016
    Keywords provided by Hopital Foch
    Pain
    Polyamine
    Cholecystectomy
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Nov 3, 2016