Clinical trial NCT06053476: Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
Official title: Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumothorax, Primary Spontaneous
VATS
Pain, Postoperative
Locoregional Anaesthesia
Thoracic Epidural
Chest Tube Drainage
Lead sponsor: Maxima Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Leiden University Medical Center
First posted: 2023-09-25
Enrollment: 366
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Recurrence rate
timeFrame: Until 1 year follow-up
measure: Pain score
timeFrame: Postoperative day 0-3
measure: Postoperative length of stay (LOS)
timeFrame: 30 postoperative days
Secondary outcomes:
measure: Quality of Recovery (QoR)
timeFrame: until 4 weeks follow-up
measure: Quality of Life (QoL)
timeFrame: until 1 year follow-up
measure: Postoperative complications
timeFrame: until 4 weeks follow-up
measure: Postoperative chest tube drainage during hospitalisation
timeFrame: 30 postoperative days
measure: Cumulative use of opioids and analgesics
timeFrame: postoperative day 0-4 and the use at 4 weeks follow-up
measure: degree of mobility
timeFrame: postoperative day 0-4
measure: Health status
timeFrame: until 1 year follow-up
measure: patient satisfaction
timeFrame: postoperative day 0-4
Other outcomes:
Locations:
city: Veldhoven
country: Netherlands
facility: Maxima MC
Study officials:
References: