Chronic Pain Following Thoracic Surgery

Pain, Postoperative Clinical Trial

— PTPS-18  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144845
• Other study ID #: PTPS-18
• Status: Completed
• Phase: N/A
• First received: June 14, 2010
• Last updated: August 27, 2011
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: August 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: October 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Death

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Thoracic surgery
Thoracoscopy or anterior thoracotomy

Locations

Country	Name	City	State
Denmark	Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of persistent postsurgical pain		Within 10 years after thoracic surgery	No
Secondary	Location of persistent postsurgical pain		Within 10 years after thoracic surgery	No
Secondary	Duration of postsurgical pain		Within 10 years after thoracic surgery	No
Secondary	Course of persistent postsurgical pain		Within 10 years after thoracic surgery	No
Secondary	Severity of postsurgical pain		Within 10 years after thoracic surgery	No
Secondary	Characteristics of persistent postsurgical pain		Within 10 years after thoracic surgery	No
Secondary	Symptoms associated with persistent postsurgical pain		Within 10 years after thoracic surgery	No
Secondary	Treatment of and effect of treatment on persistent postsurgical pain		Within 10 years after thoracic surgery	No
Secondary	Effect of postsurgical pain on activity, mood, walking ability, work, interpersonal relations, sleep and quality of life		Within 10 years after thoracic surgery	No