Recruiting

Study on High Dose Dexamethasone for Reducing Post-Surgery Pain in Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Dexamethasone on patients with lung cancer who are undergoing a specific type of surgery known as Video-Assisted Thoracoscopic Surgery (VATS) for removing parts of the lung, such as a lobectomy or segmentectomy. The purpose of the study is to see if a high dose of Dexamethasone can help reduce acute pain after surgery in patients who are identified as "high-pain-responders."

Participants in the study will receive either a high dose of Dexamethasone, calculated as 1 milligram per kilogram of body weight, or a lower dose of 8 milligrams in total. The medication will be given intravenously, which means it will be administered directly into a vein, after the patient has been put under anesthesia for the surgery. Some participants will receive a placebo instead of Dexamethasone. The study will monitor pain levels, especially when coughing, and other factors like the use of additional pain relief medications, nausea, and the length of hospital stay after surgery.

The trial will also look at other outcomes, such as the quality of recovery, any complications within 30 days after surgery, and the overall experience of the patients during their recovery. The study is expected to continue until October 2026, with recruitment starting in June 2025. The findings from this trial could help improve pain management strategies for patients undergoing lung surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide consent to participate.
You must meet certain criteria, such as being over 18 years old, understanding Danish, having a specific score on a pain scale, and being scheduled for a specific type of lung surgery.
Step 2
Pre-surgery preparation
Before your surgery, you will undergo standard pre-surgery assessments to ensure you are ready for the procedure.
You will be randomly assigned to receive either a high dose or a low dose of the medication dexamethasone.
Step 3
Medication administration
After anesthesia is administered, you will receive dexamethasone through an intravenous (IV) line. This means the medication will be given directly into your vein.
The high dose is calculated based on your weight (1 mg per kg), while the low dose is a total of 8 mg.
Step 4
Post-surgery monitoring
After surgery, your pain levels will be monitored using a numeric scale from 0 to 10, especially when you cough or walk.
Your use of additional pain relief and anti-nausea medications will be recorded during the first two days after surgery.
Step 5
Follow-up assessments
You will be asked to complete a questionnaire about your recovery on the seventh day after surgery.
Your overall health and any hospital readmissions within 30 days will be tracked.

Who can join the trial?

4 criteria

Must be older than 18 years.
Must be able to understand both written and spoken Danish.
Must have a score of 20 or higher on the Pain Catastrophizing Scale. This is a questionnaire that measures how much a person focuses on and worries about their pain.
Must be scheduled for an elective Video-Assisted Thoracoscopic Surgery (VATS) Lobectomy/Segmentectomy. This is a type of surgery on the lungs using a small camera and instruments inserted through small cuts in the chest.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with lung cancer cannot participate.
Patients who are not undergoing a specific type of surgery called VATS lobectomy/segmentectomy cannot participate. This is a type of surgery on the lungs.
Patients who are not considered "high-pain-responders" cannot participate. This means patients who do not typically experience high levels of pain after surgery.
Patients who are not within the age range of 18 to 64 years cannot participate.
Patients who are part of a vulnerable population cannot participate. This generally refers to groups who may need special protection, like children or those unable to give consent.

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Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

Dexamethasone is a type of steroid medication used in this clinical trial. It is given through an IV, which means it is administered directly into a vein. The purpose of using Dexamethasone in this trial is to help reduce pain for patients who are undergoing a specific type of lung surgery called video-assisted thoracoscopic surgery (VATS) lobectomy or segmentectomy. This medication is being tested to see if it can help manage pain better when given in different amounts to patients who are more sensitive to pain. By doing this, the trial aims to find out if Dexamethasone can improve the recovery experience for these patients after surgery.

Dexamethasone Disodium Phosphate

What is already known about the treatment

Dexamethasone – Dexamethasone is administered intravenously, meaning it is given directly into a vein, usually after anesthesia is induced. It is currently being studied in clinical trials for its effectiveness in managing pain for patients undergoing lung surgery, specifically video-assisted thoracoscopic surgery (VATS) for lobectomy or segmentectomy. The main therapeutic use of dexamethasone in this context is to reduce pain and inflammation. At the molecular level, dexamethasone works by mimicking the effects of cortisol, a natural hormone, to suppress the immune system and decrease inflammation. It is classified as a corticosteroid, a type of medication that reduces inflammation and affects the immune response.

Investigated diseases

Lung cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the disease progresses, these tumors can interfere with the lung's ability to provide oxygen to the bloodstream. The cancer can spread to other parts of the body through a process called metastasis. Lung cancer is often categorized into two main types: non-small cell lung cancer and small cell lung cancer, each with different growth patterns. The progression of the disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing.