High-dose dexamethasone to reduce pain after VATS lung surgery
High Dose Dexamethasone In High-Pain Responders Undergoing Enhanced Recovery Video-Assisted Thoracoscopic Surgery Lobectomy and Segmentectomy - A Randomized Double-Blinded Controlled Trial
This trial will test whether a single high IV dose of dexamethasone given at anesthesia induction reduces morning coughing pain after VATS lobectomy or segmentectomy for patients who score high on the Pain Catastrophizing Scale.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen, Copenhagen) |
| Trial ID | NCT07213375 on ClinicalTrials.gov |
What this trial studies
This randomized, phase 2/3 trial enrolls adult patients scheduled for elective VATS lobectomy or segmentectomy who score ≥20 on the Pain Catastrophizing Scale and randomizes them to a high-dose dexamethasone arm (1 mg/kg) or a low-dose arm (total 8 mg) given intravenously after induction of anesthesia. The primary outcome is postoperative pain when coughing on the morning after surgery, measured by numeric rating scales, with secondary goals of assessing mobilization, pulmonary complications, and length of stay. The intervention targets the postoperative inflammatory response with a single perioperative glucocorticoid dose. The trial is conducted at the Department for Cardiothoracic Surgery, Rigshospitalet, Copenhagen.
Who should consider this trial
Good fit: Adults (≥18) planning elective VATS lobectomy or segmentectomy who can read and speak Danish and score ≥20 on the Pain Catastrophizing Scale are the intended participants.
Not a fit: Patients on systemic glucocorticoids or other immunosuppressants, insulin-dependent diabetics, pregnant or breastfeeding people, those with known steroid allergy, or certain psychiatric/neurologic conditions are excluded and unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, a single high IV dose of dexamethasone could reduce morning coughing pain after VATS, making mobilization easier and potentially lowering pulmonary complications and hospital stay.
How similar studies have performed: Glucocorticoids have shown anti-inflammatory effects and reduced postoperative pain in other surgical settings, but using a high single dose targeted to high pain-catastrophizing VATS patients is a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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.
Where this trial is running
Copenhagen, Copenhagen
- Department for Cardiothoracic Surgery, Rigshospitalet — Copenhagen, Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Lasse Visby, Medical Doctor
- Email: lasse.visby@regionh.dk
- Phone: +4522246982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.