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

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lung surgery
Sponsored by
Hopital Foch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain focused on measuring Lung surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Mutualiste Montsouris
  • Hopital Foch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lung Surgery

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with chronic pain 4 months after surgery

Secondary Outcome Measures

Full Information

First Posted
October 5, 2016
Last Updated
August 13, 2019
Sponsor
Hopital Foch
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1. Study Identification

Unique Protocol Identification Number
NCT02928003
Brief Title
Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors
Acronym
DOLORPOUMON
Official Title
Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
April 16, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Lung surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lung Surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Lung surgery
Intervention Description
Genetic analysis and questionnaires
Primary Outcome Measure Information:
Title
Number of patients with chronic pain 4 months after surgery
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireille Michel-Cherqui, MD
Organizational Affiliation
Hopital Foch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
750014
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92150
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Chronic Neuropathic Pain After Lung Surgery: Prevalence and Predictive Factors

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