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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00812734
First received: December 19, 2008
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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

Study Type: Observational
Official Title: Etude épidémiologique Multicentrique Des Douleurs Neuropathiques Post-opératoires

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Rate of persistent pain at 3 and 6 months after surgery [ Time Frame: at 3 and 6 months after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 3322
Study Start Date: April 2006
Study Completion Date: September 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00812734     History of Changes
Other Study ID Numbers: CHU-0044
Study First Received: December 19, 2008
Last Updated: April 2, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on October 02, 2014