AnalgeticPhase 2/3DEXTERNCT07213375
High Dose Dexamethasone to Reduce Postoperative Pain After Video-Assisted Thoracoscopic Surgery Lobectomy /Segmentectomy
A Phase 2/3 study testing Dexamethasone in people with Analgetic and Lung Cancer (NSCLC), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to "High-pain-responders" in patients undergoing VATS lobectomy/segmentectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgetic, Lung Cancer (NSCLC), Video Assisted Thoracic Surgery (VATS)
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2025to Nov 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 year
- Able to understand written and spoken Danish language
- PCS ≥20
- Signed written informed consent form.
- Patient planned to elective VATS lobectomy/segmentectomy
Who cannot join
- Patients undergoing systemic glucocorticoid or other immunosuppressive therapies, ex-cluding inhaled steroids.
- Individuals with diabetes requiring insulin treatment.
- Pregnant or breastfeeding patients.
- Patients with known allergies to the study drug.
- Individuals with mental disabilities that may impair their capacity to provide informed consent or compromise the validity of data collection.
- Patients with diagnosed schizophrenia, active psychosis, bipolar disorder, or a history of ongoing treatment with antipsychotic and/or antidepressant medications.
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- Individuals with altered pain perception due to other conditions or injuries, such as spi-nal cord or brain injuries, severe polyneuropathies, or neurological disorders.
- Regular users of opioid medications.
- Patients requiring reoperation within the first two postoperative days.
- Individuals undergoing conversion to a surgical procedure other than VATS lobecto-my/segmentectomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department for Cardiothoracic Surgery, Rigshospitalet
Copenhagen, Copenhagen, 2100
Lasse Visby, Medical Doctor, +45 22246982, lasse.visby@regionh.dk
About this study
Official title: High Dose Dexamethasone In High-Pain Responders Undergoing Enhanced Recovery Video-Assisted Thoracoscopic Surgery Lobectomy and Segmentectomy - A Randomized Double-Blinded Controlled Trial
The aim is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to "High-pain-responders" in patients undergoing VATS lobectomy/segmentectomy.
The hypothesis is that a high dose of Dexamethasone can lower pain when coughing in the morning after VATS lobectomy/segmentectomy, in patients scoring as "High-pain-responders" on the Pain-Catastrophizing-Scale
Read the detailed description
Annually, approximately 400 anatomical resections (lobectomy and segmentectomy) are performed using video-assisted thoracoscopic surgery (VATS) at the Department of Cardiothoracic Surgery, Rigshospitalet.
Tissue damage occurs during surgery, triggering an inflammatory response.Glucocorticoids, including Dexamethasone, administered in relation to surgery, have shown anti-inflammatory effects in previous studies and the potential to reduce postoperative pain and hospitalization duration in various surgical procedures.
Previous studies have indicated that the most common complications of VATS lobectomy leading to prolonged hospitalization in patients are air leakage (27%), pneumonia (20%), and pain (15%).
A previous study from Rigshospitalet, Denmark found that half of the patients undergoing a VATS lobectomy, reported severe pain (defined as Numeric Rating Scale (NRS) ≥ 5) at some point on the day of surgery and first postoperative day. This indicates a need for better pain management following VATS lobectomy, which is confirmed by another study Rigshospitalet, Denmark that found a high rate of severe pain (NRS > 5) in the first two days after a VATS lobectomy. The median NRS score when coughing on the morning after surgery was 6.0 (5.0-8.0). Improved pain management is expected to facilitate easier mobilization, likely resulting in fewer pulmonary complications and shorter hospital stays.
The Pain Catastrophizing Scale (PCS) is a self-assessment questionnaire examining catastrophic thinking in relation to pain. The PCS score has previously been shown to correlate with postoperative pain, and in another study found that increasing scores of PCS resulted in higher pain scores, and that patients grouped as "High-pain-responders" (PCS≥20) had significantly more pain when coughing on the first postoperative day.
Previous studies, in patients undergoing a total knee arthroplasty, showed that higher doses of Dexamethasone reduced the percentage of patients experiencing moderate-severe pain postoperatively in the "High-pain-responder" group, however not in the "Low-pain-responder" group.
The aim is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to "High-pain-responders" in patients undergoing VATS lobecto-my/segmentectomy.
Safety of higher doses of glucocorticoid has previously been extensively examined and side effects are considered negligible, and several larger meta-analyses of previous studies have only minor side effects with glucocorticoids in both low and high doses when compared to placebo.
Previous studies have also performed exactly the same intervention, with same doses of Dexamethasone, in patients scheduled for knee and hip arthroplasty without any safety issues.
The hypothesis is that a high dose of Dexamethasone can lower pain when coughing in th morning after VATS lobectomy/segmentectomy, in patients scoring as "High-pain-responders" on the Pain-Catastrophizing-Scale
- Being tested
- Dexamethasone
- Keywords
- Pain catastrophizing, ERAS, VATS, Lung cancer, Minimizing pain
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Patients will receive either low dose (8mg) or high dose (1mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Low dose Dexamethasone (8mg) | Active comparator | Not described Receives: Drug: Dexamethasone |
| High dose Dexamethasone (1mg/kg) | Active comparator | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain when coughing on the morning of first postoperative day.
The primary endpoint is pain when coughing on the first morning after surgery, measured on the NRS-scale (0-10; where 0 is no pain, and 10 is the worst possible pain).
Measured: Morning of first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgeticStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lasse Visby, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213375
- Sponsor's protocol ID
- 2025-520891-25-00
- Other IDs
- 2025-520891-25-00, 2025
- Acronym
- DEXTER
- Status last verified
- Jan 2026
- First submitted
- 23 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Dexamethasone In High-Pain Responders Undergoing Enhanced Recovery Video-Assisted Thoracoscopic Surgery Lobectomy and Segmentectomy - A Randomized Double-Blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT07213375
- Acronym / sponsor ID
- DEXTER / 2025-520891-25-00
- Keywords
- Pain catastrophizing, ERAS, VATS, Lung cancer, Minimizing pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Oct 2025 (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 is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to "High-pain-responders" in patients undergoing VATS lobectomy/segmentectomy.
The hypothesis is that a high dose of Dexamethasone can lower pain when coughing in the morning after VATS lobectomy/segmentectomy, in patients scoring as "High-pain-responders" on the Pain-Catastrophizing-Scale
Detailed description
Annually, approximately 400 anatomical resections (lobectomy and segmentectomy) are performed using video-assisted thoracoscopic surgery (VATS) at the Department of Cardiothoracic Surgery, Rigshospitalet.
Tissue damage occurs during surgery, triggering an inflammatory response.Glucocorticoids, including Dexamethasone, administered in relation to surgery, have shown anti-inflammatory effects in previous studies and the potential to reduce postoperative pain and hospitalization duration in various surgical procedures.
Previous studies have indicated that the most common complications of VATS lobectomy leading to prolonged hospitalization in patients are air leakage (27%), pneumonia (20%), and pain (15%).
A previous study from Rigshospitalet, Denmark found that half of the patients undergoing a VATS lobectomy, reported severe pain (defined as Numeric Rating Scale (NRS) ≥ 5) at some point on the day of surgery and first postoperative day. This indicates a need for better pain management following VATS lobectomy, which is confirmed by another study Rigshospitalet, Denmark that found a high rate of severe pain (NRS > 5) in the first two days after a VATS lobectomy. The median NRS score when coughing on the morning after surgery was 6.0 (5.0-8.0). Improved pain management is expected to facilitate easier mobilization, likely resulting in fewer pulmonary complications and shorter hospital stays.
The Pain Catastrophizing Scale (PCS) is a self-assessment questionnaire examining catastrophic thinking in relation to pain. The PCS score has previously been shown to correlate with postoperative pain, and in another study found that increasing scores of PCS resulted in higher pain scores, and that patients grouped as "High-pain-responders" (PCS≥20) had significantly more pain when coughing on the first postoperative day.
Previous studies, in patients undergoing a total knee arthroplasty, showed that higher doses of Dexamethasone reduced the percentage of patients experiencing moderate-severe pain postoperatively in the "High-pain-responder" group, however not in the "Low-pain-responder" group.
The aim is to conduct a randomized controlled trial (RCT) with a high dose arm (1mg/kg) vs a low dose (8mg in total) of steroid (Dexamethasone) given intravenous (IV) after the induction of anesthesia to "High-pain-responders" in patients undergoing VATS lobecto-my/segmentectomy.
Safety of higher doses of glucocorticoid has previously been extensively examined and side effects are considered negligible, and several larger meta-analyses of previous studies have only minor side effects with glucocorticoids in both low and high doses when compared to placebo.
Previous studies have also performed exactly the same intervention, with same doses of Dexamethasone, in patients scheduled for knee and hip arthroplasty without any safety issues.
The hypothesis is that a high dose of Dexamethasone can lower pain when coughing in th morning after VATS lobectomy/segmentectomy, in patients scoring as "High-pain-responders" on the Pain-Catastrophizing-Scale
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose Dexamethasone (8mg) | Active comparator | Drug: Dexamethasone |
| High dose Dexamethasone (1mg/kg) | Active comparator | Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 year
- Able to understand written and spoken Danish language
- PCS ≥20
- Signed written informed consent form.
- Patient planned to elective VATS lobectomy/segmentectomy
Key exclusion criteria (10 listed)
- Patients undergoing systemic glucocorticoid or other immunosuppressive therapies, ex-cluding inhaled steroids.
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 |
|---|---|---|
| DexamethasonePatients will receive either low dose (8mg) or high dose (1mg/kg) | Drug | High dose Dexamethasone (1mg/kg), Low dose Dexamethasone (8mg) |
Primary outcome
Pain when coughing on the morning of first postoperative day.
Time frame: Morning of first postoperative day
The primary endpoint is pain when coughing on the first morning after surgery, measured on the NRS-scale (0-10; where 0 is no pain, and 10 is the worst possible pain).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexamethasone in people with Analgetic and Lung Cancer (NSCLC), 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lasse Visby, Medical Doctor (+4522246982, lasse.visby@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain when coughing on the morning of first postoperative day. (time frame: Morning of first postoperative day). 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 7 Jan 2026.