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

Launched by MAXIMA MEDICAL CENTER · Sep 22, 2023

Keywords

ClinConnect Summary

The Pneumotrial study is focused on finding the best ways to manage chest tubes and pain after surgery for a condition called primary spontaneous pneumothorax (PSP), which is when air leaks into the space between the lung and chest wall. Currently, there are no clear guidelines on how long chest tubes should stay in after surgery or the best pain management techniques, leading to differences in patient care and hospital stays. This trial is exploring whether removing the chest tube on the same day as surgery and using a specific pain relief method called a paravertebral blockade (which numbs the area around the ribs) can safely reduce hospital stays without increasing the risk of the air leak returning.

To be eligible for this trial, participants should be at least 16 years old, have had surgery for PSP, and be able to understand Dutch. The study is not open to those with certain lung conditions or previous thoracic surgeries. If you join, you can expect to receive either the new treatment approach being tested or the standard care. The goal is to improve recovery and make the experience after surgery better for everyone involved.

Gender

ALL

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