- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01300195
Prediction of Persistent Postsurgical Pain After Video-assisted Thoracic Surgery (VATS)
September 27, 2011 updated by: Rigshospitalet, Denmark
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
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kim Wildgaard, MD
- Phone Number: +45 3545 3246
- Email: wildgaard@thoracotomy.eu
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Recruiting
- Section for Surgical Pathophysiology 4074
-
Principal Investigator:
- Kim Wildgaard, MD
-
Sub-Investigator:
- Thomas Ringsted, Md
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Lung cancer patients
Description
Inclusion Criteria:
- Age < 18 years old
- Elective lung cancer surgery (VATS)
Exclusion Criteria:
- do not understand Danish
- cognitive reduction
- bilateral procedure planned
- previous thoracic surgery
- pregnant or nursing
- known nerve affection from other cause
- alcohol/substance abuse
- inability to cooperate to pain scoring/sensory examination
- > 5 mg methylprednisolone/day
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
lung cancer surgery
Patients undergoing video-assisted thoracic surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Persistent post surgical pain
Time Frame: 3 months
|
Pain intensity (Numerical Rating Scale)
|
3 months
|
Analgesic use
Time Frame: 3 months
|
type(s) and amount of analgesics used
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Anticipated)
November 1, 2012
Study Completion (Anticipated)
April 1, 2013
Study Registration Dates
First Submitted
February 18, 2011
First Submitted That Met QC Criteria
February 18, 2011
First Posted (Estimate)
February 21, 2011
Study Record Updates
Last Update Posted (Estimate)
September 28, 2011
Last Update Submitted That Met QC Criteria
September 27, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H4-2010-118#0
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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