Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Maxima MC
RECRUITING
Veldhoven
Contact Information
Primary
Quirine C.A. van Steenwijk, MD
quirine.van.steenwijk@mmc.nl
+31-40888-7243
Backup
Frank J.C. van den Broek, MD, PhD
frankvanden.broek@mmc.nl
+31-40888-8550
Time Frame
Start Date: 2023-11-08
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 366
Treatments
Active_comparator: Chest tube duration at least 3 days plus TEA
Experimental: Chest tube duration at least 3 days plus single-shot PVB
Experimental: Early chest tube removal plus TEA
Experimental: Early chest tube removal plus single-shot PVB
Sponsors
Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), ZonMw: The Netherlands Organisation for Health Research and Development, Leiden University Medical Center
Leads: Maxima Medical Center

This content was sourced from clinicaltrials.gov