NCT00812734

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 28, 2019

Status Verified

April 1, 2013

Enrollment Period

3.9 years

First QC Date

December 19, 2008

Last Update Submit

May 23, 2019

Conditions

Neuropathic Pain

Keywords

Neuropathic painchronic painpostoperativesurgeryanesthesiologyScheduled surgery

Outcome Measures

Primary Outcomes (1)

  • Rate of persistent pain at 3 and 6 months after surgery

    at 3 and 6 months after surgery

Secondary Outcomes (1)

  • Rate of persistent neuropathic pain at 3 and 6 months after surgery. Identification of risk factors collected before surgery. Links with genome.

    at 3 and 6 months after surgery

Study Arms (1)

surgery

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

Interventions

Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)PROCEDURE

Blood sampling for genomics; harvesting of a sample of intercostal muscle for proteomics (thoracotomies only)

surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Definied population

You may qualify if:

  • 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

You may not qualify if:

  • Emergency
  • Inability to fill questionnaires
  • Unreachable patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (5)

  • Niccolai P, Ouchchane L, Libier M, Beouche F, Belon M, Vedrinne JM, El Drayi B, Vallet L, Ruiz F, Biermann C, Duchene P, Chirat C, Soule-Sonneville S, Duale C, Dubray C, Schoeffler P. Persistent neuropathic pain after inguinal herniorrhaphy depending on the procedure (open mesh v. laparoscopy): a propensity-matched analysis. Can J Surg. 2015 Apr;58(2):114-20. doi: 10.1503/cjs.008314.

    PMID: 25799247BACKGROUND

  • Blanc P, Genin E, Jesson B, Dubray C, Duale C; EDONIS-gene Investigating group. Genetics and postsurgical neuropathic pain: An ancillary study of a multicentre survey. Eur J Anaesthesiol. 2019 May;36(5):342-350. doi: 10.1097/EJA.0000000000000986.

    PMID: 30882400DERIVED

  • Richez B, Ouchchane L, Guttmann A, Mirault F, Bonnin M, Noudem Y, Cognet V, Dalmas AF, Brisebrat L, Andant N, Soule-Sonneville S, Dubray C, Duale C, Schoeffler P. The Role of Psychological Factors in Persistent Pain After Cesarean Delivery. J Pain. 2015 Nov;16(11):1136-46. doi: 10.1016/j.jpain.2015.08.001. Epub 2015 Aug 20.

    PMID: 26299436DERIVED

  • Lefebvre-Kuntz D, Duale C, Albi-Feldzer A, Nougarede B, Falewee MN, Ouchchane L, Soule-Sonneville S, Bonneau J, Dubray C, Schoeffler P. General anaesthetic agents do not influence persistent pain after breast cancer surgery: A prospective nationwide cohort study. Eur J Anaesthesiol. 2015 Oct;32(10):697-704. doi: 10.1097/EJA.0000000000000215.

    PMID: 26053994DERIVED

  • Duale C, Ouchchane L, Schoeffler P; EDONIS Investigating Group; Dubray C. Neuropathic aspects of persistent postsurgical pain: a French multicenter survey with a 6-month prospective follow-up. J Pain. 2014 Jan;15(1):24.e1-24.e20. doi: 10.1016/j.jpain.2013.08.014. Epub 2013 Oct 25.

    PMID: 24373573DERIVED

MeSH Terms

Conditions

NeuralgiaChronic Pain

Interventions

Blood Specimen CollectionGenome

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesGenetic StructuresGenetic Phenomena

Study Officials

  • Christian Dualé

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

April 1, 2006

Primary Completion

March 1, 2010

Study Completion

September 1, 2011

Last Updated

May 28, 2019

Record last verified: 2013-04

Locations

FR(1)