Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)

Maxima Medical Center

Status: Enrolling

Conditions: Pneumothorax, Primary Spontaneous; Chest Tube Drainage; Locoregional Anaesthesia; Pain, Postoperative; Thoracic Epidural; VATS

Treatments: Procedure: Single-shot paravertebral block; Procedure: Late chest tube removal; Procedure: Thoracic epidural analgesia; Procedure: Early chest tube removal

Study type: Interventional

Funder types: Other

Identifiers

NCT06053476

NL84451.015.23

Details and patient eligibility

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.

Enrollment: 366 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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366 participants in 4 patient groups

Chest tube duration at least 3 days plus TEA

Active Comparator group

Treatment:

Procedure: Late chest tube removal

Procedure: Thoracic epidural analgesia

Chest tube duration at least 3 days plus single-shot PVB

Experimental group

Treatment:

Procedure: Late chest tube removal

Procedure: Single-shot paravertebral block

Early chest tube removal plus TEA

Experimental group

Treatment:

Procedure: Early chest tube removal

Procedure: Thoracic epidural analgesia

Early chest tube removal plus single-shot PVB

Experimental group

Treatment:

Procedure: Early chest tube removal

Procedure: Single-shot paravertebral block