Non-steroidal Anti-inflammatory Drugs in Pleurodesis (KETOTHORAX)

Non-steroidal Anti-inflammatory Drugs in Pleurodesis Surgery for Pneumothorax

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumothorax; Pain Management; Pleurodesis; Non-steroidal Anti-inflammatory Drugs
• Intervention / Treatment: Procedure: pleurodesis procedures; Drug: KETOPROFEN(RP19583); Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 358
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Florent LEVIEL, MD; Phone Number: 33 3 22 08 91 09; Email: leviel.florent@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • Centre Hospitalier Universitaire d'Amiens
    • Contact: Florent LEVIEL, MD; Phone Number: 33 3 22 08 91 09; Email: leviel.florent@chu-amiens.fr
    • Contact: Osama ABOU ARAB, Pr
    • Contact: Selim, MD
    • Contact: Huette, MD
    • Contact: Defrancq, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; 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)	Procedure: pleurodesis procedures; All pleurodesis procedures will be conducted with a general anesthesia. The choice of hypnotic, analgesic and neuromuscular drugs will be at the discretion of the physician. Selective orotracheal intubation will be done for all patients with a double lumen tube or a blocker according to centers habits. Regional anesthesia (serratus block, paravertebral block and erector spinae block) will be allowed and chosen at the discretion of the physician. Multimodal pain management will be allowed with the use dexamethasone, ketamine and antinociceptive drugs (nefopam, tramadol, paracetamol at the discretion of the physician. After the surgical procedure, the pleural production of liquid or air will be monitored with a chest tube connected to pleural drainage device according to centers habits. Pain will be monitored with during the hospital stay every 12 h using the pain rate scale graded from 0 to 10. Neuropathic pain will be screened at 48h, 1 months, 6 months and 1 year after the inclusion; Drug: 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)
Placebo Comparator: Control group; 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)	Procedure: pleurodesis procedures; All pleurodesis procedures will be conducted with a general anesthesia. The choice of hypnotic, analgesic and neuromuscular drugs will be at the discretion of the physician. Selective orotracheal intubation will be done for all patients with a double lumen tube or a blocker according to centers habits. Regional anesthesia (serratus block, paravertebral block and erector spinae block) will be allowed and chosen at the discretion of the physician. Multimodal pain management will be allowed with the use dexamethasone, ketamine and antinociceptive drugs (nefopam, tramadol, paracetamol at the discretion of the physician. After the surgical procedure, the pleural production of liquid or air will be monitored with a chest tube connected to pleural drainage device according to centers habits. Pain will be monitored with during the hospital stay every 12 h using the pain rate scale graded from 0 to 10. Neuropathic pain will be screened at 48h, 1 months, 6 months and 1 year after the inclusion; Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of pleural drainage	duration of pleural drainage from the time of orotracheal extubation to the time of pleural tube remove recorded in hours.	from the time of orotracheal extubation to the time of pleural tube remove

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	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	at 72 hours
cumulative postoperative opioid equivalent dose	cumulative postoperative opioid equivalent dose (tramadol, morphine, oxycodone) recorded in milligram and during the first 72h after surgery	at 72 hours
Postoperative pneumonia occurence	Postoperative pneumonia during hospital stay	From enrollment to the end of hospital stay, up to 6 months
Length of hospital stay	Length of hospital stay in days	From enrollment to the end of hospital stay, up to 6 months
homolateral or contralateral recurrence in spontaneous pneumothorax	Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 1month	at 1month
homolateral or contralateral recurrence in spontaneous pneumothorax	Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 6 months	at 6 months
homolateral or contralateral recurrence in spontaneous pneumothorax	Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 12 months	at 12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Rouen; Centre Hospitalier VALENCIENNES; Clinique Victor Pauchet

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pain management; pneumothorax; non-steroidal anti-inflammatory drugs; pleurodesis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: PI2021_843_0175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No