NCT07213375

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Analgetic
• Lung Cancer (NSCLC)
• Video Assisted Thoracic Surgery (VATS)
• Glucocorticoid

Interventions

Type	Name	Description
DRUG	Dexamethasone	Patients will receive either low dose (8mg) or high dose (1mg/kg)

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2025-10-08
• Last updated: 2026-01-07

Locations

1 site across 1 country: Denmark