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Chronic Pain Following Thoracic Surgery (PTPS-18)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kasper Grosen, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01144845
First received: June 14, 2010
Last updated: August 27, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Pain, Postoperative
 Procedure: Thoracic surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of Persistent Postsurgical Pain Following Thoracic Surgery in Patients With Pulmonary Malignancies

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Presence of persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Location of persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ] [ Designated as safety issue: No ]
  • Duration of postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ] [ Designated as safety issue: No ]
  • Course of persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ] [ Designated as safety issue: No ]
  • Severity of postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ] [ Designated as safety issue: No ]
  • Characteristics of persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ] [ Designated as safety issue: No ]
  • Symptoms associated with persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ] [ Designated as safety issue: No ]
  • Treatment of and effect of treatment on persistent postsurgical pain [ Time Frame: Within 10 years after thoracic surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 702
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thoracic surgical patients
Patients with pulmonary malignancies
 Procedure: Thoracic surgery
Thoracoscopy or anterior thoracotomy

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 14, 2010
Last Updated: August 27, 2011
Health Authority: Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013