Using NSAIDs for pain management during pleurodesis procedures
Non-steroidal Anti-inflammatory Drugs in Pleurodesis Surgery for Pneumothorax
This study tests whether using a common pain reliever during pleurodesis can help reduce pain for patients with pneumothorax without causing more problems.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 358 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06731647 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of non-steroidal anti-inflammatory drugs (NSAIDs) in managing pain during pleurodesis procedures for patients with pneumothorax. The study aims to determine whether NSAIDs can effectively reduce pain without increasing the risk of pneumothorax recurrence. Participants will receive either ketoprofen or a placebo during their pleurodesis surgery. The trial is designed to assess the balance between effective pain management and potential complications associated with NSAID use.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require pleurodesis for pneumothorax, with or without minimal lung resection.
Not a fit: Patients who are minors, pregnant, or have contraindications to NSAIDs or other pain management medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer pain management option for patients undergoing pleurodesis, potentially reducing reliance on opioids.
How similar studies have performed: While the use of NSAIDs in pain management is common, the specific application in pleurodesis is less explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age≥18-year-old * pneumothorax with an indication of pleurodesis * with or without minimal lung resection * via thoracotomy or thoracoscopy Exclusion Criteria: * Minor patient * Pregnant, parturient or breast-feeding patient * Severe polytrauma (associated with the presence of a Vittel criterion) * Purulent pleurisy * Hemopneumothorax * Lactose hyper sensibility * Contraindications to NSAID * Contraindications to tramadol * Contraindications to paracetamol * Curative anticoagulation * Patients under guardians or deprived of their liberty * Patient refusal
Where this trial is running
Amiens
- Centre Hospitalier Universitaire d'Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Florent LEVIEL, MD
- Email: leviel.florent@chu-amiens.fr
- Phone: 33 3 22 08 91 09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.