Study on the Effects of Ketoprofen and Drug Combination in Patients Undergoing Pleurodesis Surgery for Pneumothorax

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What is this study about?

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.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent is required to participate.

Eligibility includes being 18 years or older, having pneumothorax requiring surgery, and agreeing to use effective contraception if applicable.

2 surgery and initial treatment

The patient will undergo pleurodesis surgery, which may include minor lung resection.

Post-surgery, the patient will receive medications to manage pain and aid recovery.

3 medication administration

The patient will receive ketoprofen as a solution for injection to manage inflammation and pain.

Additional medications may include nefopam and tramadol for pain relief, administered via infusion or oral routes.

The patient may also receive paracetamol orally for pain management.

4 monitoring and assessment

The patient’s recovery will be monitored, focusing on the duration of pleural drainage and pain levels.

Pain will be assessed using a numerical scale at various intervals post-surgery, including immediately after surgery and at specific hours and days following the procedure.

5 follow-up evaluations

The patient will be evaluated for any recurrence of pneumothorax at 1 month, 6 months, and 1 year after surgery.

The efficiency of the surgical procedure will be assessed by measuring drain productivity and the duration of bubbling.

6 completion of trial participation

The trial is expected to conclude by May 2028, with the patient’s participation ending after the final follow-up evaluations.

The patient’s overall health and any post-operative complications will be reviewed before concluding their involvement in the study.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Centre Hospitalier De Valenciennes Valenciennes France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Cxlqglmx Vauziy Penrpgd df Bivcwl Amiens France
Hvgniss Pfazt Aggwx Lin Bywsfetpb Arras France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.05.2024

Trial locations

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.

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 ID:
2024-511226-32-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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