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Polyamine-low Diet to Prevent Postoperative Pain After Cholecystectomy

NCT ID: NCT02083003

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery

Keywords

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Pain Polyamine Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Polyamine low-diet

Intervention Type DIETARY_SUPPLEMENT

Liberal alimentation

No specific alimentary diet

Group Type ACTIVE_COMPARATOR

Liberal alimentation

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Polyamine low-diet

Intervention Type DIETARY_SUPPLEMENT

Liberal alimentation

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Poyldol plus (Nutrialys) No specific alimentary recommendation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD

Role: STUDY_CHAIR

Hopital Foch

Locations

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Hôpital de la Croix Saint-Simon

Paris, Hauts de Seine, France

Site Status

Countries

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France

Other Identifiers

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2011-A01675-36

Identifier Type: OTHER

Identifier Source: secondary_id

2011/68

Identifier Type: -

Identifier Source: org_study_id