Chronic Pain Following Thoracic Surgery (PTPS-18)

August 27, 2011 updated by: Kasper Grosen, University of Aarhus

Study of Persistent Postsurgical Pain Following Thoracic Surgery in Patients With Pulmonary Malignancies

Pain that persists after the healing of a surgical wound has previously been described as an important, but often unrecognized clinical problem. Persistent postsurgical (chronic postoperative pain) is the consequence of either ongoing inflammation or more common neuropathic pain as a result of surgical damage to peripheral nerves.

Previous studies have shown that chronic pain is a frequent and serious complication following thoracic surgery. However, the prevalence of chronic pain following both thoracoscopy and anterior thoracotomy in patients with pulmonary malignancies is poorly characterized and the impact of this pain on patients' lives remains unclear. Thus, this study aims to investigate the prevalence of chronic pain following thoracoscopy or anterior thoracotomy, and the severity and impact of persistent post-surgical pain on daily life.

This study is working with several hypotheses: 1.) persistent postsurgical pain following lung cancer surgery is predominantly of neuropathic nature and the presence of neuropathic symptoms increases the severity of postsurgical pain and reduces the patient's quality of life, 2.) the prevalence of chronic pain is reduced over time, and 3.) less invasive thoracic surgical interventions reduces the risk of the development of chronic pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

702

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

  • Denmark
      • Aarhus N, Denmark, DK-8200
        • Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who underwent thoracic surgery due to pulmonary malignancies at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark

Description

Inclusion Criteria:

  • Patients who previously underwent thoracic surgery with lung resection from January 2000 to december 2009

Exclusion Criteria:

  • Death

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Thoracic surgical patients
Patients with pulmonary malignancies
Procedure: Thoracic surgery
Thoracoscopy or anterior thoracotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of persistent postsurgical pain
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Location of persistent postsurgical pain
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery
Duration of postsurgical pain
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery
Course of persistent postsurgical pain
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery
Severity of postsurgical pain
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery
Characteristics of persistent postsurgical pain
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery
Symptoms associated with persistent postsurgical pain
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery
Treatment of and effect of treatment on persistent postsurgical pain
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery
Effect of postsurgical pain on activity, mood, walking ability, work, interpersonal relations, sleep and quality of life
Time Frame: Within 10 years after thoracic surgery
Within 10 years after thoracic surgery

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Kasper Grosen, PhDS, MHScS, RN, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
  • Study Director: Hans K Pilegaard, MD, Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
  • Study Chair: Mogens P Jensen, MD, PhD, Department of Rheumatology, Aarhus University Hospital, Aarhus Hospital, Denmark

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

April 1, 2010

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (ESTIMATE)

June 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 30, 2011

Last Update Submitted That Met QC Criteria

August 27, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTPS-18

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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