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Recruiting NCT06731647

Non-steroidal Anti-inflammatory Drugs in Pleurodesis

Phase II Interventional Non-steroidal Anti-inflammatory Drugs Pleurodesis Pneumothorax Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pleurodesis procedures, KETOPROFEN(RP19583), Placebo.
Who it may be relevant to
Registry conditions: Non-steroidal Anti-inflammatory Drugs, Pleurodesis, Pneumothorax, Pain Management. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 th
  • 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)
  • 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)

Primary outcome measures

  • duration of pleural drainage [Time frame: from the time of orotracheal extubation to the time of pleural tube remove]
Secondary outcome measures (7)
  • postoperative pain [Time frame: at 72 hours]
  • cumulative postoperative opioid equivalent dose [Time frame: at 72 hours]
  • Postoperative pneumonia occurence [Time frame: From enrollment to the end of hospital stay, up to 6 months]
  • Length of hospital stay [Time frame: From enrollment to the end of hospital stay, up to 6 months]
  • homolateral or contralateral recurrence in spontaneous pneumothorax [Time frame: at 1month]
  • homolateral or contralateral recurrence in spontaneous pneumothorax [Time frame: at 6 months]
  • homolateral or contralateral recurrence in spontaneous pneumothorax [Time frame: at 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Centre Hospitalier Universitaire d'Amiens — Amiens

Identifiers

NCT: NCT06731647 · PI2021_843_0175

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗