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Polyamine-free Diet to Prevent Post Surgery Hyperalgesia

NCT00304850 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2009-12-29

No results posted yet for this study

Summary

After surgery, sensitization and hyperexcitability of central nervous system result in acute and long lasting postoperative pain. It has been shown that N-methyl-D-aspartate (NMDA) receptors antagonist (such as ketamine) prevent this adverse neuroplasticity and potentiate analgesic drugs efficacy. Polyamines (putrescine, spermidine, spermine) are essential components of cells functioning and are also known as allosteric modulators of NMDA receptors. In animal studies, polyamine-free diet has confirmed these antinociceptive properties. This research aims at evaluating anti hyperalgesic properties of polyamine-free diet in women operated on breast cancer versus kétamine

Conditions

Interventions

BEHAVIORAL

polyamine-free diet

Polyamine-free diet in the 7 days befor surgery

DRUG

Ketamine or placebo

Peroperative and post operative (48h) ketamine injection

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Insurance CNP foundation

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Pierre MAURETTE, Pr · DAR 3 -Pellegrin hospital-33076 Bordeaux - France

  • Genevieve CHENE, Pr · University hospital - 33076 Bordeaux - France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00304850 on ClinicalTrials.gov