Neuropathic PainNCT01068457
Chronic Pain After Thoracotomy (Video Assisted Thoracic Surgery - VATS)
An observational study of Neuropathic Pain and Thoracic Surgery, Video Assisted, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This is an explorative study investigating potential nerve injury after VATS. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neuropathic Pain, Thoracic Surgery, Video Assisted, Chronic Pain
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Apr 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung cancer patients
Who may be able to join
- Able to understand and give consent
- Can read
- Residing in Denmark
Who cannot join
- Unable to understand the written information in Danish
- Abuse (Medicine, Drugs, Alcohol)
- Severe psychiatric Illness
- Conflicting neurological disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Section for Surgical Pathophysiology 4074 andSection of Acute Pain management and Palliative Medicine.
Copenhagen, 2100
About this study
Official title: Chronic Pain After Thoracotomy (VATS)
This is an explorative study investigating potential nerve injury after VATS.
- Keywords
- persistent pain, neuropathic pain, Thoracic Surgery, Video Assisted, Chronic Pain
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PTPS | Patients with pain after VATS | |
| Pain free | Patients reporting no pain late after VAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thresholds via QST
Measured: Late postoperatively (3months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068457
- Sponsor's protocol ID
- VATS-hb2008-059
- Status last verified
- Jul 2010
- First submitted
- 8 Feb 2010
- Last updated
- 14 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
PubMed 19307137
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Thoracotomy (VATS)
- ClinicalTrials.gov ID
- NCT01068457
- Acronym / sponsor ID
- VATS-hb2008-059
- Keywords
- persistent pain, neuropathic pain, Thoracic Surgery, Video Assisted, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (actual)
- First posted
- 15 Feb 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.
This is an explorative study investigating potential nerve injury after VATS.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTPS | – | –Patients with pain after VATS |
| Pain free | – | –Patients reporting no pain late after VAT |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients
Key inclusion criteria (3 listed)
- Able to understand and give consent
- Can read
- Residing in Denmark
Key exclusion criteria (4 listed)
- Unable to understand the written information in Danish
- Abuse (Medicine, Drugs, Alcohol)
- Severe psychiatric Illness
- Conflicting neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thresholds via QST
Time frame: Late postoperatively (3months)
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 14 Jul 2010.
- Background: PubMed 19307137Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neuropathic Pain and Thoracic Surgery, Video Assisted, run by Copenhagen University Hospital, Rigshospitalet 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 3 inclusion and 4 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 14 Jul 2010. 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?
Thresholds via QST (time frame: Late postoperatively (3months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01068457, which also lists 1 linked publication.
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 14 Jul 2010.