Pain, PostoperativeNCT01300195
Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)
An observational study of Pain, Postoperative, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Apr 2013
- 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: Lung cancer patients
Who may be able to join
- Age < 18 years old
- Elective lung cancer surgery (VATS)
Who cannot join
- do not understand Danish
- cognitive reduction
- bilateral procedure planned
- previous thoracic surgery
- pregnant or nursing
- known nerve affection from other cause
Show all 9Show fewer
- alcohol/substance abuse
- inability to cooperate to pain scoring/sensory examination
- > 5 mg methylprednisolone/day
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Section for Surgical Pathophysiology 4074
Copenhagen, 2100
Kim Wildgaard, MD
Thomas Ringsted, Md
About this study
Official title: Factors Predicting Persistent Post-surgical Pain After Video-assisted Thoracic Surgery (VATS)
Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery
- Conditions
- Pain, Postoperative
- Keywords
- VATS, standardized surgery, persistent pain
- Medical subject headings
- Pain, Postoperative
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 | Patients undergoing video-assisted thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent post surgical pain
Pain intensity (Numerical Rating Scale)
Measured: 3 months
Analgesic use
type(s) and amount of analgesics used
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2012 (estimated)
- Study completionApr 2013 (estimated)
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 Pain, PostoperativeStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Dept. of thoracic Surgery, Dept. of cardio-thoracic anaesthesia, Dept. Surgical PAthophysiology, all Blegdamsvej 9, 2100-Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300195
- Sponsor's protocol ID
- H4-2010-118#0
- Status last verified
- Sep 2011
- First submitted
- 18 Feb 2011
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.
PubMed 23328340
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting Persistent Post-surgical Pain After Video-assisted Thoracic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT01300195
- Acronym / sponsor ID
- H4-2010-118#0
- Conditions
- Pain, Postoperative
- Keywords
- VATS, standardized surgery, persistent pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Dept. of thoracic Surgery, Dept. of cardio-thoracic anaesthesia, Dept. Surgical PAthophysiology, all Blegdamsvej 9, 2100-Copenhagen, Denmark
- Study start
- Feb 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 21 Feb 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.
Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lung cancer surgery | – | –Patients undergoing video-assisted thoracic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients
Key inclusion criteria (2 listed)
- Age < 18 years old
- Elective lung cancer surgery (VATS)
Key exclusion criteria (9 listed)
- do not understand Danish
- cognitive reduction
- bilateral procedure planned
- previous thoracic surgery
- pregnant or nursing
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
Persistent post surgical pain
Time frame: 3 months
Pain intensity (Numerical Rating Scale)
Analgesic use
Time frame: 3 months
type(s) and amount of analgesics used
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
- Derived from this study: PubMed 23328340Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.
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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.
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 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim Wildgaard, MD (+45 3545 3246, wildgaard@thoracotomy.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent post surgical pain (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT01300195, 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 28 Sep 2011.