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Chronic Pain Following Thoracic Surgery (PTPS-18)

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ClinicalTrials.gov Identifier: NCT01144845
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : August 30, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Pain, Postoperative Procedure: Thoracic surgery

Study Design

Study Type : Observational
Actual Enrollment : 702 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of Persistent Postsurgical Pain Following Thoracic Surgery in Patients With Pulmonary Malignancies
Study Start Date : April 2010
Primary Completion Date : June 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Presence of persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ]

Secondary Outcome Measures :
  1. Location of persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ]
  2. Duration of postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ]
  3. Course of persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ]
  4. Severity of postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ]
  5. Characteristics of persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ]
  6. Symptoms associated with persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ]
  7. Treatment of and effect of treatment on persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ]
  8. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Death
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144845


Locations
Denmark
Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby
Aarhus N, Denmark, DK-8200
Sponsors and Collaborators
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: Vibeke Hjortdal, MD, Professor, DMSc, PhD 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
More Information

Responsible Party: Kasper Grosen, PhD fellow, Master of Health Sciences, RN, University of Aarhus
ClinicalTrials.gov Identifier: NCT01144845     History of Changes
Other Study ID Numbers: PTPS-18
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

Keywords provided by Kasper Grosen, University of Aarhus:
Thoracotomy
Thoracic Surgery
Thoracic Surgical Procedures
Thoracic Surgery, Video-Assisted
Lung Neoplasms
Thoracic Nerves

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms