Lung CancerNCT05599386
Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery
An observational study of Lung Cancer, run by Jannie Bisgaard Stæhr at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Preoperative test
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2022to 6 Aug 2024
- 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: Public University hospital
Who may be able to join
- Adults independent of sex with an age of ≥ 18 years
- Patients scheduled for VATS as a part of either examination or radical treatment of lung cancer
Who cannot join
- Patients who are unable to understand oral and written information.
- Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
- Pregnant and nursing women.
- Patients receiving a planned preoperative epidural blockade during their stay.
- Patients converted to open surgery.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aalborg University Hospital
Aalborg, Region of Northern Jutland, 9000
About this study
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).
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Preoperative test
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative testDiagnostic test
Patients are subject to quantitative sensory testing, questionnaires, and biomarker analysis prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patients Undergoing VATS | Only one group as primary endpoints are continous Receives: Diagnostic Test: Preoperative test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale
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.
Measured: 48 hours postoperative
Numerical Rating Scale
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
Measured: 365 days postoperative
Secondary outcomes (4)
Total equipotent opioid dose
48 hours postoperative
Measured: Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
Time to first administration of opioid
48 hours postoperative
Measured: Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
Mobilisation
Time in hours to full mobilisation defined as walking with or without aids.
Measured: 48 hours postoperative
Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Nov 2022
- Primary completion6 Aug 2023
- Study completion6 Aug 2024 (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 Lung CancerStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jannie Bisgaard Stæhr
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor-investigator, Jannie Bisgaard Stæhr, Aalborg University Hospital
- Investigators
- Jannie Bisagaard, MD, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599386
- Sponsor's protocol ID
- AAUH-VATS-02
- Status last verified
- Dec 2023
- First submitted
- 24 Oct 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sperling PK, Giordano R, Vollert J, Arendt-Nielsen L, Danielsen AV, Rasmussen BS, Bisgaard J, Petersen KK. Exploration of Different Machine Learning Methods and Domains of Predictors for Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Surgery. Clin J Pain. 2026 Mar 1;42(3):e1347. doi: 10.1097/AJP.0000000000001347.
PubMed 41677238
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Acute and Persistent Postoperative Pain in Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT05599386
- Acronym / sponsor ID
- AAUH-VATS-02
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jannie Bisgaard StæhrUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 6 Aug 2023 (actual)
- Study completion
- 6 Aug 2024 (estimated)
- First posted
- 31 Oct 2022 (actual)
- 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.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Undergoing VATS | – | Diagnostic Test: Preoperative testOnly one group as primary endpoints are continous |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Public University hospital
Key inclusion criteria (2 listed)
- Adults independent of sex with an age of ≥ 18 years
- Patients scheduled for VATS as a part of either examination or radical treatment of lung cancer
Key exclusion criteria (5 listed)
- Patients who are unable to understand oral and written information.
- Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.
- Pregnant and nursing women.
- Patients receiving a planned preoperative epidural blockade during their stay.
- Patients converted to open surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative testPatients are subject to quantitative sensory testing, questionnaires, and biomarker analysis prior to surgery. | Diagnostic test | Patients Undergoing VATS |
Primary outcome
Numerical Rating Scale
Time frame: 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
Time frame: 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
4 secondary outcomes
Total equipotent opioid dose
Time frame: Total equipotent opioid dose in milligrams during the first 48 hours after surgery.
Time to first administration of opioid
Time frame: Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids
Mobilisation
Time frame: 48 hours postoperative
Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 41677238Sperling PK, Giordano R, Vollert J, Arendt-Nielsen L, Danielsen AV, Rasmussen BS, Bisgaard J, Petersen KK. Exploration of Different Machine Learning Methods and Domains of Predictors for Chronic Postsurgical Pain After Video-Assisted Thoracoscopic Surgery. Clin J Pain. 2026 Mar 1;42(3):e1347. doi: 10.1097/AJP.0000000000001347.
- Individual participant dataSharing planned: No
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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.
Jannie Bisagaard, MD, PhD principal investigator
Aalborg University Hospital
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 Lung Cancer, run by Jannie Bisgaard Stæhr 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 5 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 8 Dec 2023. 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?
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?
Numerical Rating Scale (time frame: 48 hours postoperative). 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 NCT05599386, 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 8 Dec 2023.