Actively Recruiting
Non-steroidal Anti-inflammatory Drugs in Pleurodesis Surgery for Pneumothorax
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-03-19
358
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
C
Centre Hospitalier VALENCIENNES
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and pain management effects of non-steroidal anti-inflammatory drugs (NSAIDs) during pleurodesis surgery for pneumothorax. There is debate about using NSAIDs in this surgery because they might interfere with the pleurodesis process and increase the risk of pneumothorax coming back. The investigators believe NSAIDs can be safe and improve pain control without raising this risk. Participants will either receive ketoprofen, an NSAID, with one intravenous dose followed by five oral doses every 12 hours for 72 hours, or a placebo with a similar schedule. All patients will undergo pleurodesis surgery under general anesthesia with pain management options allowed at the doctor's discretion. The study uses a double-blind, randomized design to compare these treatments. During the hospital stay, pain will be assessed every 12 hours using a pain scale. Researchers will monitor the duration of pleural drainage and track postoperative pain, opioid use, pneumonia occurrence, hospital stay length, and pneumothorax recurrence at multiple time points up to one year. Neuropathic pain will also be screened at 48 hours, 1 month, 6 months, and 1 year after treatment. The study participation may last up to 6 months or longer depending on follow-up.
CONDITIONS
Brief Title
Non-steroidal Anti-inflammatory Drugs in Pleurodesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of pneumothorax with indication for pleurodesis
- Surgery performed via thoracotomy or thoracoscopy
- Patients with or without minimal lung resection
You will not qualify if you...
- Under 18 years old (minor patient)
- Pregnant, parturient, or breastfeeding patients
- Severe polytrauma with Vittel criteria
- Presence of purulent pleurisy
- Hemopneumothorax
- Lactose hypersensitivity
- Contraindications to NSAIDs
- Contraindications to tramadol
- Contraindications to paracetamol
- Receiving curative anticoagulation
- Under guardianship or deprived of liberty
- Patient refusal
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to hospital discharge (duration varies per participant)
Participants undergo pleurodesis surgery under general anesthesia with various pain management strategies. After surgery, pleural fluid or air is monitored with a chest tube connected to a drainage device. Pain is assessed every 12 hours during the hospital stay.
Daily in-hospital monitoring visits
Duration - 72 hours
Participants receive either ketoprofen or placebo: one intravenous dose followed by 5 doses every 12 hours over 72 hours.
Dosing every 12 hours for a total of 6 doses
Duration - Up to 12 months
Participants are monitored for postoperative pain, opioid use, pneumonia occurrence, length of hospital stay, and recurrence of pneumothorax at 1 month, 6 months, and 12 months after surgery.
Pain and neuropathic pain assessments at 48 hours, 1 month, 6 months, and 12 months; additional follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Centre Hospitalier Universitaire d'Amiens
Amiens, France, 80054
Actively Recruiting
Research Team
F
Florent LEVIEL, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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