Centre Hospitalier Universitaire Amiens Picardie
Amiens, France
RecruitingPneumothorax
Study on the Effects of Ketoprofen and Drug Combination in Patients Undergoing Pleurodesis Surgery for Pneumothorax
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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 certain medications used during a procedure called pleurodesis surgery, which is performed to treat a condition known as pneumothorax. Pneumothorax occurs when air leaks into the space between the lung and chest wall, causing the lung to collapse. The study aims to evaluate the use of nonsteroidal anti-inflammatory drugs (NSAIDs) in this surgical context. The medications being studied include ketoprofen, nefopam, sodium chloride, tramadol, paracetamol, and cellulose, microcrystalline. Some of these medications are used to manage pain and inflammation, while others serve as supportive treatments during the procedure.
The purpose of the study is to determine if NSAIDs are as effective as other treatments in terms of reducing the time needed for pleural drainage, which is the removal of fluid or air from the pleural space after surgery. Participants in the study will receive one of the medications or a placebo, and their recovery will be monitored over a period of time. The study will assess various factors, including the duration of drainage, pain relief, and any complications that may arise after the surgery.
Throughout the study, participants will be closely observed to ensure their safety and to gather data on the effectiveness of the treatments. The study will also track the recurrence of pneumothorax and any other medical or surgical complications that may occur. This research is important for improving the management of pneumothorax and enhancing recovery after pleurodesis surgery.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- The patient must have a condition called **pneumothorax**, which is when air leaks into the space between the lung and chest wall, causing the lung to collapse. This should be for a specific type of surgery called **video-exclusive surgical indication**, which may or may not include a small lung surgery known as **atypical resection**.
- The patient must be **18 years old or older**.
- The patient must provide **written or oral consent** to participate in the study, meaning they agree to join the study after understanding what it involves.
- The patient must be part of a **social security scheme**, which is a system that provides financial support for healthcare.
- Women who can have children must use **highly effective contraception** to prevent pregnancy during the study. This can include methods like combined hormonal birth control (pills, patches, or rings), devices placed inside the uterus, surgical procedures, or choosing not to have sex.
Who cannot join the trial?
5 criteria
- Patients who have had a **pleurodesis surgery** for the treatment of **pneumothorax** cannot participate. **Pleurodesis surgery** is a procedure to stick the lung to the chest wall to prevent it from collapsing. **Pneumothorax** is a condition where air leaks into the space between the lung and chest wall, causing the lung to collapse.
- Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
- Patients who do not belong to the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
- Both male and female patients are eligible, but those who do not meet other criteria cannot participate.
- Patients who are considered part of a **vulnerable population** cannot participate. A **vulnerable population** includes individuals who may have limited ability to give informed consent or are at higher risk of harm.
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Verified Verified Centre Hospitalier Universitaire Rouen
Rouen, France
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Investigated drugs
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) are being studied in this trial to see if they are as effective as other pain management options after pleurodesis surgery, which is performed to treat pneumothorax. These medications are commonly used to reduce pain and inflammation. The trial aims to determine if using NSAIDs affects the time it takes for drainage after the surgery.
What is already known about the treatment
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) – These medications are typically administered orally or intravenously and are used to reduce pain and inflammation. In the context of pleurodesis surgery for pneumothorax, NSAIDs are being studied to determine if they are as effective as other pain management options without prolonging drainage time. They are widely recognized in medical literature for their ability to inhibit enzymes called cyclooxygenases, which play a key role in the formation of inflammatory chemicals in the body. NSAIDs are classified as anti-inflammatory and analgesic agents, commonly used for pain relief and reducing inflammation.
Investigated diseases
Pneumothorax – Pneumothorax is a condition where air enters the space between the lung and the chest wall, causing the lung to collapse partially or completely. It can occur spontaneously or as a result of injury or medical procedures. Symptoms often include sudden chest pain and shortness of breath. The progression of pneumothorax can vary; in some cases, the air may be reabsorbed naturally, while in others, medical intervention is required to remove the air and allow the lung to re-expand. Recurrent episodes may occur, especially if the underlying cause is not addressed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511226-32-00Estimated enrolment358 patientsSponsorCentre Hospitalier Universitaire Amiens Picardie
sourced from the EU Clinical Trials Register and site verification
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