NCT01144845

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
702

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 30, 2011

Status Verified

August 1, 2011

Enrollment Period

2 months

First QC Date

June 14, 2010

Last Update Submit

August 27, 2011

Conditions

Keywords

ThoracotomyThoracic SurgeryThoracic Surgical ProceduresThoracic Surgery, Video-AssistedLung NeoplasmsThoracic Nerves

Outcome Measures

Primary Outcomes (1)

  • Presence of persistent postsurgical pain

    Within 10 years after thoracic surgery

Secondary Outcomes (8)

  • Location of persistent postsurgical pain

    Within 10 years after thoracic surgery

  • Duration of postsurgical pain

    Within 10 years after thoracic surgery

  • Course of persistent postsurgical pain

    Within 10 years after thoracic surgery

  • Severity of postsurgical pain

    Within 10 years after thoracic surgery

  • Characteristics of persistent postsurgical pain

    Within 10 years after thoracic surgery

  • +3 more secondary outcomes

Study Arms (1)

Thoracic surgical patients

Patients with pulmonary malignancies

Procedure: Thoracic surgery

Interventions

Thoracoscopy or anterior thoracotomy

Thoracic surgical patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby

Aarhus N, DK-8200, Denmark

Location

MeSH Terms

Conditions

Pain, PostoperativeLung Neoplasms

Interventions

Thoracic Surgical Procedures

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Kasper Grosen, PhDS, MHScS, RN

    Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, Denmark

    PRINCIPAL INVESTIGATOR
  • Hans K Pilegaard, MD

    Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, Denmark

    STUDY DIRECTOR
  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD fellow, Master of Health Sciences, RN

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 16, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2010

Study Completion

October 1, 2010

Last Updated

August 30, 2011

Record last verified: 2011-08

Locations