RecruitingPhase 2NCT06731647

Non-steroidal Anti-inflammatory Drugs in Pleurodesis

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


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

358 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria12

  • 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

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Interventions

PROCEDUREpleurodesis 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

DRUGKETOPROFEN(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)

DRUGPlacebo

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)


Locations(1)

Centre Hospitalier Universitaire d'Amiens

Amiens, France

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NCT06731647


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