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AuthorisedTherapeutic confirmatory (Phase III)Interventional

Evaluation of the Impact of a Strategy of Perioperative NSAID Suppression in Patients Undergoing Video-assisted Thoracic Surgery (VATS) on the Presence of Chronic Postoperative Pain (CPOP): a Randomised Clinical Trial (EVADRAINS)

After keyhole surgery on the chest (called video-assisted thoracic surgery, or VATS), some people experience pain that lasts for months. Doctors often prescribe non-steroidal anti-inflammatory drugs (NSAIDs), such as ketoprofen, to manage swelling and soreness immediately after surgery. However, researchers want to see if avoiding these medications around the time of an operation might actually help prevent long-term nerve or surgical pain. In this clinical trial, adults having keyhole chest surgery will be randomly put into one of two groups. One group will receive an anti-inflammatory painkiller (ketoprofen), while the other group will receive an inactive dummy treatment (placebo) instead. All patients will still receive strong, standard pain relief to keep them comfortable. Researchers will track pain levels, recovery, and overall quality of life for three months after surgery.

At a glance

Status
Authorised
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Les Hopitaux Universitaires De Strasbourg
Enrolment target
318
Start
31 Aug 2026

What is this study about?

Having chest surgery can be a major step in treating lung or chest conditions. Nowadays, doctors often use a keyhole method called video-assisted thoracic surgery (VATS). While this technique uses small cuts and usually leads to faster healing than open surgery, some patients still go on to develop long-lasting, chronic pain in the weeks and months after their operation.

Right now, it is common to give patients anti-inflammatory medications—known as NSAIDs—around the time of surgery to help with immediate soreness and swelling. Ketoprofen is one example of these drugs. While they work well for short-term pain, scientists are now asking whether dampening the body's natural early healing response might accidentally increase the chance of pain lasting longer. This study aims to find out if avoiding these anti-inflammatory drugs during surgery helps people heal with less long-term discomfort.

By comparing patients who receive ketoprofen with those who do not, researchers hope to discover the safest, most effective way to manage pain. The results could help doctors in the UK and worldwide update their pain-relief guidelines, ensuring future surgical patients recover as comfortably and smoothly as possible.

Key takeaways

  • The trial looks at whether avoiding anti-inflammatory drugs during chest surgery reduces long-term pain.
  • It is for adults having planned keyhole chest surgery (VATS).
  • Participants will receive either the painkiller ketoprofen or a matching dummy medicine (placebo).
  • All patients will have access to full, standard pain relief throughout their hospital stay.
  • Your progress and pain levels will be tracked for three months after surgery.

Who may be eligible?

This trial is open to adults aged 18 and over who are scheduled to have keyhole chest surgery (VATS). Both men and women can take part.

To join, you must be able to understand the study and agree to follow the recovery checks. Doctors will check your medical history to make sure taking part is completely safe for you.

People who cannot safely take anti-inflammatory painkillers, those with certain kidney or stomach conditions, or patients having major emergency surgery rather than planned keyhole surgery may not be able to participate. Your surgical team will confirm if you meet all safety criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I am scheduled to have planned keyhole chest surgery (VATS).
  3. I do not have a known allergy to anti-inflammatory drugs like ibuprofen or ketoprofen.
  4. I am happy to answer brief questions about my pain and recovery for three months.
  5. I can give my own informed consent to take part in medical research.
Answer every question to see your result.

What does participation involve?

If you take part, you will be randomly placed into one of two groups by a computer, like flipping a coin. One group will receive the anti-inflammatory painkiller ketoprofen through a drip and in capsules. The other group will receive an inactive dummy medicine (a placebo). Neither you nor your doctors will know which group you are in, but you will always receive standard painkillers like paracetamol or stronger pain relievers whenever you need them.

During your stay in hospital, nurses will regularly check your pain levels using a simple 0 to 10 scale, both while resting and moving. You will also have routine blood tests, and small extra blood samples may be taken to study how your body is healing. After you go home, you will complete short questionnaires about your comfort, daily activities, and wellbeing at one month and three months. Your total time in the study will be about three months.

Potential risks and benefits

You may not receive any direct personal benefit from taking part, but your feedback could help doctors improve pain care for people having chest surgery in the future. The main risks are the usual side effects linked to anti-inflammatory medicines, which can include mild stomach upset or irritation. If you are given the placebo, your care team will closely monitor your comfort and give you other effective painkillers straight away if you feel sore. Taking part is completely voluntary, and you are free to leave the study at any time without your regular NHS medical care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    France

Common questions

Will I be left in pain if I get the dummy medicine?

No. Your comfort is the top priority. The study medicine is only one part of pain relief, and your doctors will give you other standard painkillers whenever you need them.

What is keyhole chest surgery (VATS)?

VATS stands for video-assisted thoracic surgery. It is a modern surgical technique where doctors operate inside the chest using tiny cuts and a small camera.

What is an NSAID?

NSAID stands for non-steroidal anti-inflammatory drug. Common examples include ibuprofen and ketoprofen. They reduce pain, fever, and swelling.

How long will I be involved in the trial?

You will be followed from the day of your operation until three months after surgery, mainly through brief questionnaires during your recovery.

Can I change my mind after joining?

Yes. You can withdraw from the study at any point without giving a reason, and it will not change the quality of your care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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