Non-steroidal Anti-inflammatory Drugs in Pleurodesis

NCT06731647 | Recruiting Phase 2

• 1 other identifier: PI2021_843_0175
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-steroidal Anti-inflammatory Drugs; Pleurodesis; Pneumothorax; Pain Management

Keywords

non-steroidal anti-inflammatory drugs; pleurodesis; pneumothorax; pain management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• postoperative pain

  at 72 hours

• cumulative postoperative opioid equivalent dose

  at 72 hours

• Postoperative pneumonia occurence

  From enrollment to the end of hospital stay, up to 6 months

• Length of hospital stay

  From enrollment to the end of hospital stay, up to 6 months

• homolateral or contralateral recurrence in spontaneous pneumothorax

  at 1month

Study Arms (2)

Interventional group

EXPERIMENTAL

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; Drug: KETOPROFEN(RP19583)

Control group

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

pleurodesis procedures PROCEDURE

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

Control group; Interventional group

KETOPROFEN(RP19583) DRUG

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

Placebo DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18-year-old
• pneumothorax with an indication of pleurodesis
• with or without minimal lung resection
• via thoracotomy or thoracoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Centre Hospitalier VALENCIENNES: collaborator
• Clinique Victor Pauchet: collaborator
• University Hospital, Rouen: collaborator

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Pneumothorax; Agnosia

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Florent LEVIEL, MD

CONTACT

33 3 22 08 91 09; leviel.florent@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 12, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)