Last update : 06/01/2020 | Version : 2 | ID : 60123
General | |
Identification | |
Detailed name | Epidemiological Study on Post-Surgical Neuropathic Pain |
Sign or acronym | EDONIS |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 16/03/2007 |
General Aspects | |
Medical area |
Neurology |
Health determinants |
Genetic Iatrogenic |
Keywords | chronic pain, type of surgery, neuropathic characteristics, specific tools, Health episodes, consultations, assessment, pain, prevalence |
Scientific investigator(s) (Contact) | |
Name of the director | Duale |
Surname | Christian |
Address | 63003 CLERMONT FERRAND CEDEX 01 |
Phone | + 33 (0)4 73 17 84 18 |
cduale@chu-clermontferrand.fr | |
Unit | CPC-CIC |
Organization | INSERM CIC |
Collaborations | |
Funding | |
Funding status |
Mixed |
Details | 24 % PHRC NATIONAL - INSERM - CHU DE CLERMONT-FERRAND PFIZER |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | CHU de Clermont-Ferrand |
Organisation status |
Public |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Cohort study |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | Inclusion method: prospective Other bodies active in creating this cohort: CHU, CHG, CLCC, CLINICS |
Database objective | |
Main objective | General objective: The EDONIS projects (PHRC national 2005) piloted by the Clermont-Ferrand Clinical Investigation Centre is a national multicentric epidemiological study whose primary objective is to know the prevalence of persistent pain at 3 and 6 months after surgery. This is the first prospective study of this size on chronic post-surgical pain which is a public health problem accounting for almost 15% of new consultations in specialist pain management institutions. Secondary objective: EDONIS also aims to identify pre-and peri-operative pain risk factors and to characterise its mechanisms with a focus on neuropathic factors. Eight types of conventional surgery were selected because (a) they are already known to induce persistent pain (thoracotomy, mastectomy, inguinal hernia repair), (b) they are frequently practised in France and chronic pain is an attribute (sternotomy, caesarean section, cholecystectomy, saphenectomy) or (c) surgery has a suspected risk of nerve injury (knee arthroscopy). There is also an associated ancillary genetic study. |
Inclusion criteria | Scheduled surgery identified as neuropathy-inducing |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
Population covered |
Sick population |
Gender |
Male Woman |
Geography area |
National |
Detail of the geography area | Multicentric cohort throughout France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 04/2006 |
Date of last collection (YYYY or MM/YYYY) | 06/2010 |
Size of the database | |
Size of the database (number of individuals) |
[1000-10 000[ individuals |
Details of the number of individuals | 3330 |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Clinical data Declarative data Biological data |
Clinical data (detail) |
Direct physical measures Medical registration |
Declarative data (detail) |
Paper self-questionnaire |
Biological data (detail) | Samples taken |
Presence of a biobank |
No |
Health parameters studied |
Health event/morbidity Health event/mortality |
Procedures | |
Participant monitoring |
Yes |
Details on monitoring of participants | Follow-up duration: 6 months |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=EDONIS+AND+Duale[Author] |
Description | List of publications in Pubmed |
Link to the document | J Pain 2014.pdf |
Description | main publication |
Link to the document | J Pain 2015.pdf |
Description | ancillary caesarean section |
Link to the document | CJS 2015.pdf |
Description | ancillary hernia repair |
Other information | genetic study to be published soon |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Access for collaboration with INSERM U792 team (Dr. Bouhassira) under the INSERM pain research network to improve diagnostic tools already developed by this team (DN4, QEDN) within the specific post-surgical framework. |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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