NCT06053476 Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
| NCT ID | NCT06053476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maxima Medical Center |
| Condition | Pneumothorax, Primary Spontaneous |
| Study Type | INTERVENTIONAL |
| Enrollment | 366 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 366 participants in total. It began in 2023-11-08 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 postoperative care and length of hospital stay (LOS). Chest tube and pain management are prominent factors regarding enhanced recovery after thoracic surgery, and in standardised care they are crucial to improve quality of recovery and decrease LOS. Historically, postoperative chest tubes are left in place for at least a fixed number of 3-5 days, irrespective of absence of air leakage. This period was deemed necessary for adequate pleurodesis and prevention of recurrence. However, it is suggested that removal on the same day of surgery is safe and associated with a reduced LOS. Regarding postoperative pain management, thoracic epidural analgesia (TEA) is the gold standard for postoperative pain management following video-assisted thoracic surgery (VATS). Although the analgesic effect of TEA is clear, it is associated with hypotension and urinary retention. Therefore, unilateral regional techniques, such as paravertebral blockade (PVB), are developed. The investigators hypothesize that early chest tube removal accompanied by a single-shot paravertebral blockade (PVB) for analgesia is safe regarding pneumothorax recurrence and non-inferior regarding pain, but superior regarding LOS when compared to standard conservative treatment.
Eligibility Criteria
Inclusion Criteria: * 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 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, 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06053476 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Pneumothorax, Primary Spontaneous. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06053476 currently recruiting?
Yes, NCT06053476 is actively recruiting participants. Contact the research team at quirine.van.steenwijk@mmc.nl for enrollment information.
Where is the NCT06053476 trial being conducted?
This trial is being conducted at Veldhoven, Netherlands.
Who is sponsoring the NCT06053476 clinical trial?
NCT06053476 is sponsored by Maxima Medical Center. The trial plans to enroll 366 participants.