Effect of Perioperative Ketoprofen Suppression on Chronic Pain After Video‑Assisted Thoracic Surgery: Randomized Trial in VATS Patients

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What is this study about?

The study examines individuals undergoing Thoracic surgery performed with a minimally invasive technique known as video-assisted thoracoscopic surgery. It evaluates whether stopping a class of pain‑relieving medicines called NSAID, specifically the drug ketoprofen, around the time of the operation influences the development of long‑lasting postoperative pain. The purpose is to determine if this approach reduces chronic pain three months after surgery.

Participants are randomly assigned to receive either the study medication or a harmless placebo. After the operation, pain is recorded using a simple 0‑to‑10 Numerical Rating Scale and a short questionnaire called the DN4 questionnaire that helps identify nerve‑related pain. The amount of strong pain medicines known as opioids is also monitored. Additional surveys that assess overall recovery (QoR-15) and general health (SF-36) are completed before surgery and at one and three months later. Blood samples are taken at several points to study the body’s response, and participants are followed from the day of surgery through three months after the procedure.

1 enrollment and baseline assessment

after joining the study you will sign the consent form and provide basic health information.

you will complete initial questionnaires that measure quality of life and pain expectations.

2 pre‑operative medication assignment

the study team will assign you to receive either ketoprofen (an anti‑inflammatory drug) or a placebo (inactive substance).

the medication will be prepared as oral capsules containing 200 mg of ketoprofen and an intravenous solution containing 50 mg of ketoprofen, or matching placebo capsules and saline solution.

3 surgery day – medication administration

shortly before the operation you will take the oral capsule.

during the operation an infusion of the study solution (50 mg of ketoprofen or placebo) will be given through the vein.

the medication is given only during the peri‑operative period, which includes the time before, during, and immediately after surgery.

4 immediate postoperative period

after waking in the post‑anesthesia care unit you will be asked to rate your pain on a scale from 0 to 10.

the amount of opioid pain medicine you receive will be recorded.

any adverse effects will be noted.

5 post‑operative day 1

you will rate pain again at rest and while moving.

you will answer the dn4 questionnaire, which screens for nerve‑related pain.

a blood sample will be taken for routine tests and research measurements.

if the protocol allows, you may receive additional non‑opioid pain medication as directed by the clinical team.

6 post‑operative day 3

pain rating and dn4 questionnaire will be repeated.

another blood sample will be collected for research analysis.

7 one month after surgery

you will complete the pain rating, the quality‑of‑life questionnaire (qor‑15) and the sf‑36 health survey.

a blood sample may be taken for research purposes.

8 three months after surgery

final pain rating will be performed using the same 0‑10 scale.

the dn4 questionnaire, qor‑15 and sf‑36 surveys will be completed again.

a final blood sample will be drawn for proteomic and transcriptomic analysis.

the study will collect information on any adverse events that occurred during the trial.

Who Can Join the Study?

Be an adult between 18 and 75 years old.
Plan to have video‑assisted thoracic surgery, a chest operation that uses a small camera and tiny cuts.
Be able to understand the study and give informed consent (agree to join after the doctors explain what will happen).
Have a social health insurance scheme (be covered by a regular health‑insurance plan).

Who Cannot Join the Study?

Having a history of kidney problems (called renal insufficiency) with a low kidney filtering rate (GFR less than 60 mL/min/1.73 m²).
Being unable to make legal decisions because of a legal protection status such as guardianship or curatorship.
Being pregnant or breast‑feeding.
Having a type of surgery (for example, talc surgery) that makes taking NSAIDs (non‑steroidal anti‑inflammatory drugs) unsafe.
Having any medical condition that makes taking NSAIDs unsafe (a contraindication to NSAIDs).
Having diabetes or an actively treated cancer other than lung cancer.
Having an irregular heart rhythm (heart rhythm disorder) or having a pacemaker implanted.
Having experienced pain that lasted three months or longer at any body site during the year before surgery.
Having taken steroidal or non‑steroidal anti‑inflammatory drugs (SAIDs or NSAIDs) within three months before the planned surgery.
Having a past stomach or duodenal ulcer (a sore in the stomach or upper small intestine).
Having peripheral artery disease that is more advanced than stage 2 (significant blockage in the arteries of the arms or legs).
Having an active inflammatory disease (such as rheumatoid arthritis or similar) that is currently being treated.
Having used opioid pain medicines within three months before surgery, or having used them continuously for more than three months during the year before surgery.
Needing urgent surgery (surgery that must be performed immediately).
Being unable to receive normal saline solution (0.9% NaCl) or any of the ingredients used in the placebo.
Having a planned hospital stay that would occur during the time the study is being conducted.
Being enrolled in another interventional drug clinical trial at the same time.
Being unable to understand the study information because of comprehension difficulties.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Crhyal Htmdtvxrezp Udfusdqrluoht Di Dbtii	Dijon	France
Cqturm Hddepmknubo Uafpakycekrok Ryyhl	Reims	France
Hxkgggnv Urjxwnbwnrdhjy Srrlashszm &hvpvck Hzmwcws dp Hduunjwrdwp	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.12.2026

Trial locations

Investigated Drugs:

Ketoprofen capsules
These are oral capsules that contain ketoprofen, a non‑steroidal anti‑inflammatory drug (NSAID). In the study participants take the capsules by mouth to help manage pain after their thoracic surgery. The medication works by reducing inflammation and pain signals, which may influence the development of chronic postoperative pain.

Ketoprofen infusion solution (Aguettant)
This is a liquid form of ketoprofen that is given directly into a vein (intravenous infusion) during the peri‑operative period. The infusion delivers the drug straight into the bloodstream, providing rapid pain relief and anti‑inflammatory effects around the time of surgery. It is used in the trial to see how IV ketoprofen influences long‑term pain after the operation.

Ketoprofen infusion solution (Medisol)
This product is a ketoprofen solution that must be mixed with a small amount of fluid before being given by IV infusion. Like the other ketoprofen formulations, it aims to control pain and inflammation during and after the thoracic surgery. The study includes this preparation to compare its effect on the chance of developing chronic postoperative pain.

Chronic postoperative pain – This is pain that continues for weeks or months after a surgical procedure, lasting longer than the usual healing period. It often begins as the normal discomfort from the operation and then does not fully subside. Over time the pain may become constant or intermittent and can include aching, throbbing, or pressure sensations. The persistence of this pain can affect everyday activities such as walking, lifting, or sleeping. It may develop gradually as the body’s normal recovery process slows down.

Neuropathic pain – This type of pain arises when nerves are damaged or irritated, often after surgery or injury. It is usually described as burning, tingling, or electric‑shock‑like sensations. The pain can start soon after the nerve insult and may become ongoing if the nerve does not heal properly. It often spreads beyond the original injury site and can be triggered by light touch or temperature changes. Over weeks to months the sensation can become more intense or frequent.

Trial ID:

2025-524917-96-00

Protocol code:

9797

NCT ID:

NCT07108582

Trial Phase:

Therapeutic confirmatory (Phase III)

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Effect of Perioperative Ketoprofen Suppression on Chronic Pain After Video‑Assisted Thoracic Surgery: Randomized Trial in VATS Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?