Skip to content

Impact of prescribing nonsteroidal anti-inflammatory drugs in pleurodesis surgery after pneumothorax: a prospective randomized controlled double-blind multicenter noninferiority study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511226-32-00
Enrollment
358
Registered
2024-07-30
Start date
2025-05-07
Completion date
Unknown
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pleurodesis surgery for cure of pneumothorax

Brief summary

Duration of pleural drainage (days).

Detailed description

Efficiency of analgesia: - Decimal Numerical Scale (END) for cough at post-operative H0 - END at rest at post-operative H0 - END at rest and cough upon leaving the recovery room - END at rest and cough at H6, D1, D2, Consumption of opioids (equivalent in mg of morphine), Recurrence of ipsilateral pneumothorax at 1 month, 6 months, 1 year, Efficiency of the gesture: - Drain productivity (mL) - Duration of bubbling (days), Post-operative medical and surgical complications : - Pneumonia during hospitalization (nominal) - duration of stay (days) - Need for re-intervention during stay (nominal)

Interventions

DRUGKETOPROFEN
DRUGNEFOPAM
DRUGSODIUM CHLORIDE
DRUGTRAMADOL
DRUGPARACETAMOL
DRUGCELLULOSE

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Duration of pleural drainage (days).

Secondary

MeasureTime frame
Efficiency of analgesia: - Decimal Numerical Scale (END) for cough at post-operative H0 - END at rest at post-operative H0 - END at rest and cough upon leaving the recovery room - END at rest and cough at H6, D1, D2, Consumption of opioids (equivalent in mg of morphine), Recurrence of ipsilateral pneumothorax at 1 month, 6 months, 1 year, Efficiency of the gesture: - Drain productivity (mL) - Duration of bubbling (days), Post-operative medical and surgical complications : - Pneumonia during hospitalization (nominal) - duration of stay (days) - Need for re-intervention during stay (nominal)

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026