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Non-steroidal Anti-inflammatory Drugs in Pleurodesis

ConditionsNon-steroidal Anti-inflammatory DrugsPleurodesisPneumothoraxPain Management
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18-year-old

pneumothorax with an indication of pleurodesis

with or without minimal lung resection

via thoracotomy or thoracoscopy

Disqualifiers

Minor patient

Pregnant, parturient or breast-feeding patient

Severe polytrauma (associated with the presence of a Vittel criterion)

Purulent pleurisy

Trial design

Design model

Parallel

Treatments tested in this trial

  • pleurodesis procedures

    Procedure/Surgery

    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)

Treatment groups

358 Participants
are divided into 2 treatment groups
Group A: Interventional groupExperimental treatment 2 interventions
Group B: Control groupPlacebo comparator 2 interventions

Trial outcomes

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.

Time frame
from the time of orotracheal extubation to the time of pleural tube remove

Secondary outcomes

1

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

Time frame
at 72 hours
2

cumulative postoperative opioid equivalent dose

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

Time frame
at 72 hours
3

Postoperative pneumonia occurence

Postoperative pneumonia during hospital stay

Time frame
From enrollment to the end of hospital stay, up to 6 months
4

Length of hospital stay

Length of hospital stay in days

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire, Amiens

Lead sponsor

Centre Hospitalier VALENCIENNES

Collaborator

Clinique Victor Pauchet

Collaborator

University Hospital, Rouen

Collaborator

Source ClinicalTrials.gov
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