Non-steroidal Anti-inflammatory Drugs in Pleurodesis

Phase 2

Recruiting

• Conditions: Non-steroidal Anti-inflammatory Drugs; Pleurodesis; Pneumothorax; Pain Management
• Interventions: Procedure: pleurodesis procedures; Drug: KETOPROFEN(RP19583); Drug: Placebo

• Registration Number: NCT06731647
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended in a multimodal pain management to reduce pain intensity and to spare opioid use. However, there is a controversy in its use in pleurodesis surgery as it could block the process of pleurodesis in surgical pneumothorax. In addition, NSAIDs could increase the risk of pneumothorax recurrence.

The investigators hypothesized that NSAIDs are safe during pleurodesis with a better pain management without increasing the risk of pneumothorax reccurence.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-09
• Study First Posted: 2024-12-12
• Study Start: 2025-02-01
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2027-11
• Study Completion: 2028-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 358

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	pleurodesis procedures	one intravenous dose of ketoprofen 100 mg followed by 5 doses every 12 h of ketoprofen LP 100 mg (a total regimen of 6 doses of ketoprofen every 12 h for 72h)
Interventional group	KETOPROFEN(RP19583)	one intravenous dose of ketoprofen 100 mg followed by 5 doses every 12 h of ketoprofen LP 100 mg (a total regimen of 6 doses of ketoprofen every 12 h for 72h)
Control group	pleurodesis procedures	placebo of ketoprofen with the schema of administration consisting in the administration of one intravenous dose of 100 ml of NaCl 0.9% following 6 oral intakes of a placebo pill every 12h (a total regimen of 6 doses of placebo of NSAID every 12 h for 72h)
Control group	Placebo	placebo of ketoprofen with the schema of administration consisting in the administration of one intravenous dose of 100 ml of NaCl 0.9% following 6 oral intakes of a placebo pill every 12h (a total regimen of 6 doses of placebo of NSAID every 12 h for 72h)

Primary Outcome Measures

Name	Time	Method
duration of pleural drainage	from the time of orotracheal extubation to the time of pleural tube remove	duration of pleural drainage from the time of orotracheal extubation to the time of pleural tube remove recorded in hours.

Secondary Outcome Measures

Name	Time	Method
postoperative pain	at 72 hours	postoperative pain during the first 72h after surgery assessed by the numeric rating scale (NRS) every 12 h. Pain is defined by an NRS\>3 out of 10
cumulative postoperative opioid equivalent dose	at 72 hours	cumulative postoperative opioid equivalent dose (tramadol, morphine, oxycodone) recorded in milligram and during the first 72h after surgery
Postoperative pneumonia occurence	From enrollment to the end of hospital stay, up to 6 months	Postoperative pneumonia during hospital stay
Length of hospital stay	From enrollment to the end of hospital stay, up to 6 months	Length of hospital stay in days
homolateral or contralateral recurrence in spontaneous pneumothorax	at 12 months	Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 12 months

Trial Locations

Locations (1)

Centre Hospitalier Universitaire d'Amiens; 🇫🇷 Amiens, France