NCT02083003

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4 surgery

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

March 7, 2014

Last Update Submit

November 2, 2016

Conditions

Surgery

Keywords

PainPolyamineCholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Pain intensity for the 7 days

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

    7 days

Secondary Outcomes (6)

  • Pain scores measured on the day of surgery,

    12 hours

  • frequency of impeded hospital discharge the day of surgery

    24 hours

  • Each day pain

    7 days

  • Quality of life

    7 days

  • Residual pain

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Polyamine low-diet

EXPERIMENTAL

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

Liberal alimentation

ACTIVE COMPARATOR

No specific alimentary diet

Dietary Supplement: Liberal alimentation

Interventions

Polyamine low-dietDIETARY_SUPPLEMENT
Also known as: Poyldol plus (Nutrialys)
Polyamine low-diet
Liberal alimentationDIETARY_SUPPLEMENT
Also known as: No specific alimentary recommendation
Liberal alimentation

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Croix Saint-Simon

Paris, Hauts de Seine, 75020, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marc Fischler, MD

    Hopital Foch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 11, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

FR(1)