Improving chest tube and pain management after surgery for spontaneous pneumothorax
Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial
This study is testing whether taking out chest tubes right after surgery for a collapsed lung can help patients recover faster and feel less pain compared to keeping them in for several days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 366 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Maxima Medical Center Academic / other |
| Locations | 1 site (Veldhoven) |
| Trial ID | NCT06053476 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the optimal postoperative management of chest tubes and pain relief in patients who have undergone surgery for primary spontaneous pneumothorax. The study will compare traditional practices of leaving chest tubes in place for several days against the potential benefits of early removal on the same day of surgery. Additionally, it will assess different pain management techniques, including thoracic epidural analgesia and single-shot paravertebral blocks, to enhance recovery and reduce hospital stays. The goal is to establish evidence-based guidelines for postoperative care in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 16 and older who are undergoing surgery for primary spontaneous pneumothorax and can provide informed consent.
Not a fit: Patients with previous thoracic surgery, underlying lung diseases, or contraindications for thoracic epidural analgesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and reduced hospital stays for patients undergoing surgery for spontaneous pneumothorax.
How similar studies have performed: Other studies have suggested that early chest tube removal is safe, indicating potential success for this approach, although this specific methodology may be novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Veldhoven
- Maxima MC — Veldhoven, Netherlands (Recruiting)
Study contacts
- Study coordinator: Quirine C.A. van Steenwijk, MD
- Email: quirine.van.steenwijk@mmc.nl
- Phone: +31-40888-7243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.