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Epidemiologic Multicentre Study of Neuropathic Post-surgical Pain (EDONIS)

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ClinicalTrials.gov Identifier: NCT00812734
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : April 4, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This cohort study aims to know the prevalence at 3 and 6 months after surgery, of persistent pain, as well as to describe the neuropathic features of this pain. It includes more than 3000 patients scheduled for different types of surgery, some of them already known to induce persistent pain, some being frequent procedures with no additional data. Clinical and genetical risk factors will be searched.

Condition or disease Intervention/treatment
Neuropathic Pain Procedure: Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 3322 participants
Official Title: Etude épidémiologique Multicentrique Des Douleurs Neuropathiques Post-opératoires
Study Start Date : April 2006
Primary Completion Date : March 2010
Study Completion Date : September 2011
Groups and Cohorts

Group/Cohort Intervention/treatment
surgery Procedure: Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)
Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)


Outcome Measures

Primary Outcome Measures :
  1. Rate of persistent pain at 3 and 6 months after surgery [ Time Frame: at 3 and 6 months after surgery ]

Secondary Outcome Measures :
  1. Rate of persistent neuropathic pain at 3 and 6 months after surgery. Identification of risk factors collected before surgery. Links with genome. [ Time Frame: at 3 and 6 months after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Definied population
Criteria

Inclusion Criteria:

  • Agreement to the study
  • Scheduled for one of the following surgeries :

    • caesarean section
    • inguinal hernia repair
    • mastectomy
    • cholecystectomy under laparoscopy
    • saphenectomy (excluding harvesting for coronary bypass)
    • sternotomy
    • thoracotomy
    • knee arthroscopy
  • Major over 18 years

Exclusion Criteria:

  • Emergency
  • Inability to fill questionnaires
  • Unreachable patients
Contacts and Locations

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): NCT00812734


Locations
France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Pfizer
Investigators
Principal Investigator: Christian Dualé University Hospital, Clermont-Ferrand
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00812734     History of Changes
Other Study ID Numbers: CHU-0044
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by University Hospital, Clermont-Ferrand:
Neuropathic pain
chronic pain
postoperative
surgery
anesthesiology
Scheduled surgery

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms