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Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

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ClinicalTrials.gov Identifier: NCT02083003
Recruitment Status : Terminated (End of commercialization of low polyamin diet)
First Posted : March 11, 2014
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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
Surgery Dietary Supplement: Polyamine low-diet Dietary Supplement: Liberal alimentation Phase 4

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Study Type : Interventional  (Clinical Trial)
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 : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

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 Name: Poyldol plus (Nutrialys)

Active Comparator: Liberal alimentation
No specific alimentary diet
Dietary Supplement: Liberal alimentation
Other Name: No specific alimentary recommendation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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) .

  4. Quality of life [ Time Frame: 7 days ]
    QLQC30 Questionnaire (version 3)

  5. Residual pain [ Time Frame: 30 days ]
    Pain score (numerical scale from 0 to 10)

  6. 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



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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083003


Locations
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France
Hôpital de la Croix Saint-Simon
Paris, Hauts de Seine, France, 75020
Sponsors and Collaborators
Hopital Foch
Investigators
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Study Chair: Marc Fischler, MD Hopital Foch
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Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02083003    
Other Study ID Numbers: 2011/68
2011-A01675-36 ( Other Identifier: ANSM )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Keywords provided by Hopital Foch:
Pain
Polyamine
Cholecystectomy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations