ThoracotomyNCT01274871
Sensory Changes From Chest Drains
An observational study of Thoracotomy and Chronic Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Does chest drains contribute to the post thoracotomy pain syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracotomy, Chronic Pain
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post thoracotomy patients after lung cancer in Denmark
Who may be able to join
- Age > 18
- Able to cooperate
- able to speak and read Danish
Who cannot join
- repeat surgery
- cognitive dysfunction
- other nerve injury on the thorax
- abuse (medicine/ alcohol etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Late Sensory Changes From Chest Drain Insertion During Thoracotomy
Does chest drains contribute to the post thoracotomy pain syndrome
- Conditions
- Thoracotomy, Chronic Pain
- Keywords
- Thoracotomy, Chronic Pain, persistent post-surgical pain
- Medical subject headings
- 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 |
|---|---|---|
| lung cancer surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (NRS)
Measured: 3 years postoperatively
Sensory thresholds
Measured: 3 years postoperatively
Secondary outcomes (1)
Psychometrics (HADS)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startDec 2009
- Primary completionApr 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracotomyStudies 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
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274871
- Sponsor's protocol ID
- H-B-2008-059/drain
- Status last verified
- Jan 2011
- First submitted
- 11 Jan 2011
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Sensory Changes From Chest Drain Insertion During Thoracotomy
- ClinicalTrials.gov ID
- NCT01274871
- Acronym / sponsor ID
- H-B-2008-059/drain
- Conditions
- Thoracotomy, Chronic Pain
- Keywords
- Thoracotomy, Chronic Pain, persistent post-surgical pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 12 Jan 2011 (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.
Does chest drains contribute to the post thoracotomy pain syndrome
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer surgery | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post thoracotomy patients after lung cancer in Denmark
Key inclusion criteria (3 listed)
- Age > 18
- Able to cooperate
- able to speak and read Danish
Key exclusion criteria (4 listed)
- repeat surgery
- cognitive dysfunction
- other nerve injury on the thorax
- abuse (medicine/ alcohol etc)
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
Pain (NRS)
Time frame: 3 years postoperatively
Sensory thresholds
Time frame: 3 years postoperatively
1 secondary outcome
Psychometrics (HADS)
Time frame: 3 years
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 12 Jan 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.
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 Thoracotomy and Chronic Pain, 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 12 Jan 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?
Pain (NRS) (time frame: 3 years postoperatively). The study lists 2 primary outcomes in all. 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 12 Jan 2011.