AI-Powered Research

- Patients with primary spontaneous pneumothorax (PSP) and referred for surgery
due to recurrence, prolonged air leak (>=5 days), accompanied hemothorax or a
profession at risk (diving, polar explorers, working with compressed air). -
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.

Exclusion Criteria

- 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, lungfibrosis,
chronic obstructive pulmonary disease (COPD), active pneumonia, pulmonary
ipsilateral malignancy
- Contra-indications for thoracic epidural analgesia (TEA) (infection at skin
site, increased intracranial pressure, non-correctable coagulopathy, sepsis and
mechanical spine obstruction)
- Patients chronically 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study encompasses two primary outcome measures:<br /><br>1. Pain (non-inferiority): the proportion of NRS scores >=4, defined as the<br /><br>number of NRS scores >=4 divided by the total number of NRS measurements<br /><br>obtained during POD 0-3. A minimum of 11 NRS scores will be collected (1 at the<br /><br>recovery room and 10 afterwards on the Ward).<br /><br>2. Length of stay (days): total number of in-hospital days including<br /><br>readmissions due to complications or recurrence within 30 days.<br /><br>There is also a safety measure: absolute number of patients with recurrence<br /><br>with a maximum difference of 9 recurrences. Recurrence is defined as having an<br /><br>ipsilateral recurrent pneumothorax after chest tube removal, confirmed by X-ray<br /><br>or CT within 1-year, requiring reintervention (either tube thoracostomy or<br /><br>reoperation) or hospital readmission.</p><br>

Secondary Outcome Measures