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

Last updated: May 6, 2025
Sponsor: Maxima Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Trauma

Treatment

Single-shot paravertebral block

Thoracic epidural analgesia

Early chest tube removal

Clinical Study ID

NCT06053476
NL84451.015.23
  • Ages > 16
  • All Genders

Study 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

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 evidentsecondary pneumothorax. Previously made CT scans, within a time range of maximum 5years, are accepted. The identification of blebs or bullae on CT scan is not definedas secondary pneumothorax.

Exclusion

Exclusion Criteria:

  • Previous ipsilateral thoracic surgery (except diagnostic thoracoscopy only) oripsilateral thoracic radiotherapy

  • Underlying lung disease that provoked the pneumothorax (secondary pneumothorax):genetically proven Birt-Hogg-Dubé syndrome, periodic pneumothorax in female patientsin reproductive age with known endometriosis (or known catamenial pneumothorax),pulmonary cystic fibrosis, active pneumonia, lung fibrosis, chronic obstructivepulmonary 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 postoperativebaseline opioid requirement will be higher and TEA remains the preferred techniquefor these patients

  • Allergic reactions to analgesics used in the study

Study Design

Total Participants: 366
Treatment Group(s): 4
Primary Treatment: Single-shot paravertebral block
Phase:
Study Start date:
November 08, 2023
Estimated Completion Date:
November 01, 2028

Connect with a study center

  • Maxima MC

    Veldhoven, 5504 DB
    Netherlands

    Active - Recruiting

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