RecruitingPhase 2Phase 3NCT07213375

High Dose Dexamethasone to Reduce Postoperative Pain After Video-Assisted Thoracoscopic Surgery Lobectomy /Segmentectomy

High Dose Dexamethasone In High-Pain Responders Undergoing Enhanced Recovery Video-Assisted Thoracoscopic Surgery Lobectomy and Segmentectomy - A Randomized Double-Blinded Controlled Trial


Sponsor

Rigshospitalet, Denmark

Enrollment

80 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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.

Interventions

DRUGDexamethasone

Patients will receive either low dose (8mg) or high dose (1mg/kg)


Locations(1)

Department for Cardiothoracic Surgery, Rigshospitalet

Copenhagen, Copenhagen, Denmark

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NCT07213375


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