Actively Recruiting
Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
Led by Maxima Medical Center · Updated on 2025-05-09
366
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
M
Maxima Medical Center
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients operated for primary spontaneous pneumothorax (PSP)
- Age 16 years or older
- Able to read and understand the Dutch language
- Mentally able to give informed consent
- Have a preoperative chest CT scan within the past 5 years to exclude secondary pneumothorax
You will not qualify if you...
- Previous surgery or radiotherapy on the same side of the chest (except diagnostic thoracoscopy only)
- Underlying lung diseases causing pneumothorax such as Birt-Hogg-Dubé syndrome, endometriosis-related pneumothorax in reproductive-age females, cystic fibrosis, active pneumonia, lung fibrosis, COPD, or lung cancer on the same side
- Contraindications for thoracic epidural analgesia (infection at skin site, increased intracranial pressure, uncorrectable bleeding problems, sepsis, or spine obstruction)
- Chronic opioid use for more than 3 months
- Allergic reactions to the pain medications used in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maxima MC
Veldhoven, Netherlands, 5504 DB
Actively Recruiting
Research Team
Q
Quirine C.A. van Steenwijk, MD
CONTACT
F
Frank J.C. van den Broek, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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