Status:
RECRUITING
Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
Lead Sponsor:
Maxima Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Pneumothorax, Primary Spontaneous
VATS
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Guidelines lack high quality evidence on optimal postoperative chest tube and pain management after surgery for primary spontaneous pneumothorax (PSP). This results in great variability in postoperati...
Eligibility Criteria
Inclusion
- All patients operated for PSP
- Age ≥ 16 years
- Able to read and understand the Dutch language
- Mentally able to provide informed consent
- Patients should have a preoperative chest CT scan in order to exclude evident secondary pneumothorax. Previously made CT scans, within a time range of maximum 5 years, are accepted. The identification of blebs or bullae on CT scan is not defined as secondary pneumothorax.
Exclusion
- Previous ipsilateral thoracic surgery (except diagnostic thoracoscopy only) or ipsilateral thoracic radiotherapy
- Underlying lung disease that provoked the pneumothorax (secondary pneumothorax): genetically proven Birt-Hogg-Dubé syndrome, periodic pneumothorax in female patients in reproductive age with known endometriosis (or known catamenial pneumothorax), pulmonary cystic fibrosis, active pneumonia, lung fibrosis, chronic obstructive pulmonary disease (COPD), pulmonary ipsilateral malignancy
- Contra-indications for TEA (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, sepsis and mechanical spine obstruction)
- Patients chronically (\>3 months) using opioids will be excluded since postoperative baseline opioid requirement will be higher and TEA remains the preferred technique for these patients
- Allergic reactions to analgesics used in the study
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT06053476
Start Date
November 8 2023
End Date
November 1 2028
Last Update
May 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maxima MC
Veldhoven, Netherlands, 5504 DB