Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery
Study Details
Study Description
Brief Summary
The aim of this observational study is to investigate if preoperative quantitative sensory testing, anxiety and depression symptoms, and biological markers are associated with the risk of developing acute and chronic postoperative pain after video-assisted Thoracoscopic surgery (VATS).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This observational study examine acute and chronic postoperative pain in patients undergoing VATS. In the study preoperative biomarkers, quantitative sensory testing and questionnaires are used to create prediction models for acute and chronic postoperative pain. The study will serve as background information on the risk factors and predictive factors as well as an exploration of the impact of surgical stress from VATS on circulation microRNA and inflammatory mediators.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients Undergoing VATS Only one group as primary endpoints are continous |
Diagnostic Test: Preoperative test
Patients are subject to quantitative sensory testing, questionnaires, and biomarker analysis prior to surgery.
|
Outcome Measures
Primary Outcome Measures
- Numerical Rating Scale [48 hours postoperative]
Pain intensity on a Numerical Rating Scale ranging from 0 indicating no pain to 10 indicating worst pain imaginable during the first two postoperative days.
- Numerical Rating Scale [365 days postoperative]
Pain intensity on a Numerical Rating Scale ranging from 0 indicating no pain to 10 indicating worst pain imaginable at follow up. Collected using the Brief Pain Index
Secondary Outcome Measures
- Total equipotent opioid dose [Total equipotent opioid dose in milligrams during the first 48 hours after surgery.]
48 hours postoperative
- Time to first administration of opioid [Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids]
48 hours postoperative
- Mobilisation [48 hours postoperative]
Time in hours to full mobilisation defined as walking with or without aids.
- Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish [Measured twice. Once 48 hours after surgery or at non fixed time(on average 4 days and a maximum of 3 months) as well as at 365 days]
Patients are asked to fill out a questionnaire rating their general satisfaction with pain management and sufficiency of pain treatment on a scale from 0 to 10. The questionnaire also assess whether the patients had any perceived side effects and how uncomfortable they were on a scale from 0 to 10.
Other Outcome Measures
- Examination of the level of inflammatory biomarkers (IL-6, IL-8, TNFa, etc.) and circulation microRNA [48 hours postoperative]
Change in expression of microRNA and Inflammatory mediators from before surgery until two days after surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults independent of sex with an age of ≥ 18 years
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Patients scheduled for VATS as a part of either examination or radical treatment of lung cancer
Exclusion Criteria:
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Patients who are unable to understand oral and written information.
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Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
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Pregnant and nursing women.
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Patients receiving a planned preoperative epidural blockade during their stay.
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Patients converted to open surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aalborg University Hospital | Aalborg | Region Of Northern Jutland | Denmark | 9000 |
Sponsors and Collaborators
- Jannie Bisgaard Stæhr
- Aalborg University
Investigators
- Principal Investigator: Jannie Bisagaard, MD, PhD, Aalborg University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAUH-VATS-02