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| Name | Class |
|---|---|
| Centre Hospitalier VALENCIENNES | OTHER |
| Clinique Victor Pauchet | OTHER |
| University Hospital, Rouen | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | 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) |
|
| Control group | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| duration of pleural drainage | duration of pleural drainage from the time of orotracheal extubation to the time of pleural tube remove recorded in hours. | from the time of orotracheal extubation to the time of pleural tube remove |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 72 hours |
| cumulative postoperative opioid equivalent dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florent LEVIEL, MD | Contact | 33 3 22 08 91 09 | leviel.florent@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Amiens | Recruiting | Amiens | 80054 | France |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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|
| 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) |
|
cumulative postoperative opioid equivalent dose (tramadol, morphine, oxycodone) recorded in milligram and during the first 72h after surgery
| at 72 hours |
| Postoperative pneumonia occurence | Postoperative pneumonia during hospital stay | From enrollment to the end of hospital stay, up to 6 months |
| Length of hospital stay | Length of hospital stay in days | From enrollment to the end of hospital stay, up to 6 months |
| homolateral or contralateral recurrence in spontaneous pneumothorax | Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 1month | at 1month |
| homolateral or contralateral recurrence in spontaneous pneumothorax | Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 6 months | at 6 months |
| homolateral or contralateral recurrence in spontaneous pneumothorax | Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 12 months | at 12 months |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |