High Dose Dexamethasone to Reduce Postoperative Pain After Video-Assisted Thoracoscopic Surgery Lobectomy /Segmentectomy
Recruiting · NCT07213375 · Interventional (participants receive a specific treatment) · Lead sponsor: Rigshospitalet, Denmark
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Department for Cardiothoracic Surgery, Rigshospitalet - Copenhagen, Copenhagen, Denmark