Clinical trial NCT01144845: Chronic Pain Following Thoracic Surgery
Official title: Study of Persistent Postsurgical Pain Following Thoracic Surgery in Patients With Pulmonary Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: Thoracotomy
Thoracic Surgery
Thoracic Surgical Procedures
Thoracic Surgery, Video-Assisted
Lung Neoplasms
Thoracic Nerves
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 702
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Death

Primary outcomes:
measure: Presence of persistent postsurgical pain
timeFrame: Within 10 years after thoracic surgery
Secondary outcomes:
measure: Location of persistent postsurgical pain
timeFrame: Within 10 years after thoracic surgery
measure: Duration of postsurgical pain
timeFrame: Within 10 years after thoracic surgery
measure: Course of persistent postsurgical pain
timeFrame: Within 10 years after thoracic surgery
measure: Severity of postsurgical pain
timeFrame: Within 10 years after thoracic surgery
measure: Characteristics of persistent postsurgical pain
timeFrame: Within 10 years after thoracic surgery
measure: Symptoms associated with persistent postsurgical pain
timeFrame: Within 10 years after thoracic surgery
measure: Treatment of and effect of treatment on persistent postsurgical pain
timeFrame: Within 10 years after thoracic surgery
measure: Effect of postsurgical pain on activity, mood, walking ability, work, interpersonal relations, sleep and quality of life
timeFrame: Within 10 years after thoracic surgery
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby
Study officials:
affiliation: Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, Denmark
name: Kasper Grosen, PhDS, MHScS, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, Denmark
name: Hans K Pilegaard, MD
role: STUDY_DIRECTOR
affiliation: Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, Denmark
name: Vibeke Hjortdal, MD, Professor, DMSc, PhD
role: STUDY_CHAIR
affiliation: Department of Rheumatology, Aarhus University Hospital, Aarhus Hospital, Denmark
name: Mogens P Jensen, MD, PhD
role: STUDY_CHAIR
References: