Pain, PostoperativePTPS-18NCT01144845
Chronic Pain Following Thoracic Surgery
An observational study of Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Thoracic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 702 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent thoracic surgery due to pulmonary malignancies at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Who may be able to join
- Patients who previously underwent thoracic surgery with lung resection from January 2000 to december 2009
Who cannot join
- Death
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby
Aarhus N, DK-8200
About this study
Official title: Study of Persistent Postsurgical Pain Following Thoracic Surgery in Patients With Pulmonary Malignancies
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.
- Conditions
- Pain, Postoperative
- Being tested
- Thoracic surgery
- Keywords
- Thoracotomy, Thoracic Surgery, Thoracic Surgical Procedures, Thoracic Surgery, Video-Assisted, Lung Neoplasms, Thoracic Nerves
- Medical subject headings
- Pain, Postoperative, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic surgeryProcedure or surgery
Thoracoscopy or anterior thoracotomy
| Study group | Role | What they receive |
|---|---|---|
| Thoracic surgical patients | Patients with pulmonary malignancies Receives: Procedure: Thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of persistent postsurgical pain
Measured: Within 10 years after thoracic surgery
Secondary outcomes (8)
Location of persistent postsurgical pain
Measured: Within 10 years after thoracic surgery
Duration of postsurgical pain
Measured: Within 10 years after thoracic surgery
Course of persistent postsurgical pain
Measured: Within 10 years after thoracic surgery
Severity of postsurgical pain
Measured: Within 10 years after thoracic surgery
Characteristics of persistent postsurgical pain
Measured: Within 10 years after thoracic surgery
Symptoms associated with persistent postsurgical pain
Measured: Within 10 years after thoracic surgery
Treatment of and effect of treatment on persistent postsurgical pain
Measured: Within 10 years after thoracic surgery
Effect of postsurgical pain on activity, mood, walking ability, work, interpersonal relations, sleep and quality of life
Measured: Within 10 years after thoracic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 702 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasper Grosen, University of Aarhus
- Investigators
- Kasper Grosen, PhDS, MHScS, RN, Principal investigator, Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, DenmarkHans K Pilegaard, MD, Study director, Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, DenmarkVibeke Hjortdal, MD, Professor, DMSc, PhD, Study chair, Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, DenmarkMogens P Jensen, MD, PhD, Study chair, Department of Rheumatology, Aarhus University Hospital, Aarhus Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144845
- Sponsor's protocol ID
- PTPS-18
- Acronym
- PTPS-18
- Status last verified
- Aug 2011
- First submitted
- 14 Jun 2010
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Persistent Postsurgical Pain Following Thoracic Surgery in Patients With Pulmonary Malignancies
- ClinicalTrials.gov ID
- NCT01144845
- Acronym / sponsor ID
- PTPS-18 / PTPS-18
- Conditions
- Pain, Postoperative
- Keywords
- Thoracotomy, Thoracic Surgery, Thoracic Surgical Procedures, Thoracic Surgery, Video-Assisted, Lung Neoplasms, Thoracic Nerves
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 702 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thoracic surgical patients | – | Procedure: Thoracic surgeryPatients with pulmonary malignancies |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent thoracic surgery due to pulmonary malignancies at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Skejby, Denmark
Key inclusion criteria (1 listed)
- Patients who previously underwent thoracic surgery with lung resection from January 2000 to december 2009
Key exclusion criteria (1 listed)
- Death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic surgeryThoracoscopy or anterior thoracotomy | Procedure or surgery | Thoracic surgical patients |
Primary outcome
Presence of persistent postsurgical pain
Time frame: Within 10 years after thoracic surgery
8 secondary outcomes
Location of persistent postsurgical pain
Time frame: Within 10 years after thoracic surgery
Duration of postsurgical pain
Time frame: Within 10 years after thoracic surgery
Course of persistent postsurgical pain
Time frame: Within 10 years after thoracic surgery
Severity of postsurgical pain
Time frame: Within 10 years after thoracic surgery
Characteristics of persistent postsurgical pain
Time frame: Within 10 years after thoracic surgery
Symptoms associated with persistent postsurgical pain
Time frame: Within 10 years after thoracic surgery
Treatment of and effect of treatment on persistent postsurgical pain
Time frame: Within 10 years after thoracic surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasper Grosen, PhDS, MHScS, RN principal investigator
Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, Denmark
Hans K Pilegaard, MD study director
Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, Denmark
Vibeke Hjortdal, MD, Professor, DMSc, PhD study chair
Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital, Skejby, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of persistent postsurgical pain (time frame: Within 10 years after thoracic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2011.