Chronic Pain Following Thoracic Surgery (PTPS-18)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Actual Primary Completion Date :	June 2010
Actual Study Completion Date :	October 2010

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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
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