Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery (IncisionPain)

October 28, 2016 updated by: Hopital Foch
The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on the surgical approach. The posterolateral approach is compared to the axillary approach especially in term of development of a chronic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

209

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
      • Suresnes, France, 92151
        • 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

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing thoracic surgery by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,

Description

Inclusion Criteria:

  • patients undergoing thoracic surgery intervention by posterolateral or axillary thoracotomy, having no exclusion criteria for the study,

Exclusion Criteria:

  • planned surgery by thoracoscopy or extended surgery,
  • mental disability,
  • vulnerable person within the meaning of French law,
  • inability to communicate by phone,
  • 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Posterolateral thoracotomy
Surgeons perform a posterolateral thoracotomy
Procedure: Posterolateral thoracotomy
Axillary thoracotomy
Surgeons perform an axillary thoracotomy
Procedure: Axillary thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain
Time Frame: 4 months
Prevalence of pain 4 months after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early postoperative pain
Time Frame: 7 days

Evolution of pain from postoperative day 1 to postoperative day 6 ("pain trajectory") Prevalence of pain 5 to 7 days after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain).

Clinical examination to detect modification of skin sensibility
7 days
Characteristics of chronic pain
Time Frame: 4 months

Characteristics are notably:

  • its localization and intensity,
  • its neuropathic origin,
  • its impact on daily life,
  • required analgesic treatment,
  • need for a specific pain consultation
4 months
Quality of life
Time Frame: 4 months
Specific questionnaire
4 months
Catastrophism
Time Frame: 4 months
Score of Sullivan
4 months
Anxiety
Time Frame: 4 months
Stai trait
4 months
Preventive role of epidural analgesia
Time Frame: 4 months
Proportion of patients with chronic pain in each cohort who had had a postoperative thoracic epidural analgesia
4 months

Collaborators and Investigators

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

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/50
  • 2013- A01641-44 (Other Identifier: ANSM)

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.

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