Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors (DOLORPOUMON)

August 13, 2019 updated by: Hopital Foch
Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. Surgical approach as well as other factors (genetic, psychological) could have a major and independent role in the development of the post operative pain.The main objective of this study is to identify genetic and psychological profile (cognitive and emotional) of patients who develop chronic pain after lung surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 750014
        • Institut Mutualiste Montsouris
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing lung resection surgery.
  • 18 years and older (without superior limit);
  • Affiliated to french "securité sociale"

Exclusion Criteria:

  • Emergency procedure
  • litigation or search for compensation;
  • Previous intervention in the same region;
  • Peripheral neurological pathology (polyneuropathy) or central (brain damage, multiple sclerosis …) that may interfere with the evaluation of the post-operative pain
  • Participation in another biomedical research protocol if there is an incompatibility with the present protocol.
  • mental disability
  • vulnerable person within the meaning of French law,
  • poor understanding of French.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lung Surgery
Procedure: Lung surgery
Genetic analysis and questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with chronic pain 4 months after surgery
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 10, 2017

Primary Completion (ACTUAL)

April 16, 2019

Study Completion (ACTUAL)

April 16, 2019

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (ESTIMATE)

October 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/35
  • 2016-A00045-46 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Lung surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe