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NCT Number: NCT06731647

Non-steroidal Anti-inflammatory Drugs in Pleurodesis

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire d'Amiens

Amiens, 80054, France

Location status: Recruiting

Location contact

Defrancq, MD

PRINCIPAL_INVESTIGATOR

Florent LEVIEL, MD

CONTACT

[email protected]

33 3 22 08 91 09

Huette, MD

PRINCIPAL_INVESTIGATOR

Osama ABOU ARAB, Pr

SUB_INVESTIGATOR

Selim, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

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)

Primary outcomes

  1. duration of pleural drainage

    Time frame: 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 outcomes

  1. postoperative pain

    Time frame: 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

  2. cumulative postoperative opioid equivalent dose

    Time frame: at 72 hours

    cumulative postoperative opioid equivalent dose (tramadol, morphine, oxycodone) recorded in milligram and during the first 72h after surgery

  3. Postoperative pneumonia occurence

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

    Postoperative pneumonia during hospital stay

  4. Length of hospital stay

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

    Length of hospital stay in days

  5. homolateral or contralateral recurrence in spontaneous pneumothorax

    Time frame: at 1month

    Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 1month

  6. homolateral or contralateral recurrence in spontaneous pneumothorax

    Time frame: at 6 months

    Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 6 months

  7. homolateral or contralateral recurrence in spontaneous pneumothorax

    Time frame: at 12 months

    Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Florent LEVIEL, MD

CONTACT

[email protected]

33 3 22 08 91 09

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Hospitalier VALENCIENNES
  • Clinique Victor Pauchet
  • University Hospital, Rouen

Registry information

Official study title

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

Acronym: KETOTHORAX

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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