Non-steroidal Anti-inflammatory DrugsPhase 2KETOTHORAXNCT06731647
Non-steroidal Anti-inflammatory Drugs in Pleurodesis
A Phase 2 study testing pleurodesis procedures and KETOPROFEN(RP19583) in people with Non-steroidal Anti-inflammatory Drugs and Pleurodesis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-steroidal Anti-inflammatory Drugs, Pleurodesis, Pneumothorax
- What is being tested?
- pleurodesis procedures and KETOPROFEN(RP19583)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 358 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2025to Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18-year-old
- pneumothorax with an indication of pleurodesis
- with or without minimal lung resection
- via thoracotomy or thoracoscopy
Who cannot join
- Minor patient
- Pregnant, parturient or breast-feeding patient
- Severe polytrauma (associated with the presence of a Vittel criterion)
- Purulent pleurisy
- Hemopneumothorax
- Lactose hyper sensibility
Show all 12Show fewer
- Contraindications to NSAID
- Contraindications to tramadol
- Contraindications to paracetamol
- Curative anticoagulation
- Patients under guardians or deprived of their liberty
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire d'Amiens
Amiens, 80054
Florent LEVIEL, MD, 33 3 22 08 91 09, leviel.florent@chu-amiens.fr
Osama ABOU ARAB, Pr
About this study
Official title: Non-steroidal Anti-inflammatory Drugs in Pleurodesis Surgery for Pneumothorax
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.
- Being tested
- pleurodesis procedures, KETOPROFEN(RP19583), Placebo
- Keywords
- non-steroidal anti-inflammatory drugs, pleurodesis, pneumothorax, pain management
- Medical subject headings
- Pneumothorax, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pleurodesis proceduresProcedure or 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)
PlaceboDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: pleurodesis procedures; Drug: KETOPROFEN(RP19583) |
| 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) Receives: Procedure: pleurodesis procedures; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of pleural drainage
duration of pleural drainage from the time of orotracheal extubation to the time of pleural tube remove recorded in hours.
Measured: from the time of orotracheal extubation to the time of pleural tube remove
Secondary outcomes (7)
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
Measured: at 72 hours
cumulative postoperative opioid equivalent dose
cumulative postoperative opioid equivalent dose (tramadol, morphine, oxycodone) recorded in milligram and during the first 72h after surgery
Measured: at 72 hours
Postoperative pneumonia occurence
Postoperative pneumonia during hospital stay
Measured: From enrollment to the end of hospital stay, up to 6 months
Length of hospital stay
Length of hospital stay in days
Measured: 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
Measured: at 1month
homolateral or contralateral recurrence in spontaneous pneumothorax
Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 6 months
Measured: at 6 months
homolateral or contralateral recurrence in spontaneous pneumothorax
Screen in homolateral or contralateral recurrence in spontaneous pneumothorax at 12 months
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Feb 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-steroidal Anti-inflammatory DrugsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier VALENCIENNES, Clinique Victor Pauchet, University Hospital, Rouen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731647
- Sponsor's protocol ID
- PI2021_843_0175
- Acronym
- KETOTHORAX
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-steroidal Anti-inflammatory Drugs in Pleurodesis Surgery for Pneumothorax
- ClinicalTrials.gov ID
- NCT06731647
- Acronym / sponsor ID
- KETOTHORAX / PI2021_843_0175
- Keywords
- non-steroidal anti-inflammatory drugs, pleurodesis, pneumothorax, pain management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier VALENCIENNES, Clinique Victor Pauchet, University Hospital, Rouen
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Procedure: pleurodesis procedures, 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) |
| Control group | Placebo comparator | Procedure: pleurodesis procedures, Drug: Placeboplacebo 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18-year-old
- pneumothorax with an indication of pleurodesis
- with or without minimal lung resection
- via thoracotomy or thoracoscopy
Key exclusion criteria (12 listed)
- Minor patient
- Pregnant, parturient or breast-feeding patient
- Severe polytrauma (associated with the presence of a Vittel criterion)
- Purulent pleurisy
- Hemopneumothorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pleurodesis proceduresAll 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 | Procedure or surgery | Control group, Interventional group |
| 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 | Interventional group |
| Placeboplacebo 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) | Drug | Control group |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pleurodesis procedures and KETOPROFEN(RP19583) in people with Non-steroidal Anti-inflammatory Drugs and Pleurodesis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florent LEVIEL, MD (33 3 22 08 91 09, leviel.florent@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of pleural drainage (time frame: from the time of orotracheal extubation to the time of pleural tube remove). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.