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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 year

Able to understand written and spoken Danish language

PCS ≥20

Signed written informed consent form.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexamethasone

    Drug

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Low dose Dexamethasone (8mg)Active comparator 1 intervention
Group B: High dose Dexamethasone (1mg/kg)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Morning of first postoperative day

Secondary outcomes

Other outcomes

Sponsors and contacts

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