Non-steroidal Anti-inflammatory Drugs, Pain Management, Pleurodesis, Pneumothorax
Conditions
Keywords
non-steroidal anti-inflammatory drugs, pleurodesis, pneumothorax, pain management
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.
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
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)
Sponsors
Centre Hospitalier VALENCIENNES
Clinique Victor Pauchet
University Hospital, Rouen
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| duration of pleural drainage | 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
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 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 |
| cumulative postoperative opioid equivalent dose | at 72 hours | cumulative postoperative opioid equivalent dose (tramadol, morphine, oxycodone) recorded in milligram and during the first 72h after surgery |
| Postoperative pneumonia occurence | From enrollment to the end of hospital stay, up to 6 months | Postoperative pneumonia during hospital stay |
| Length of hospital stay | From enrollment to the end of hospital stay, up to 6 months | Length of hospital stay in days |
| homolateral or contralateral recurrence in spontaneous pneumothorax | at 1month | Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 1month |
Countries
France
Contacts
Primary ContactFlorent LEVIEL, MD
Outcome results
None listed