Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the best ways to manage chest tubes and pain after surgery for primary spontaneous pneumothorax (PSP). There is little high-quality evidence guiding postoperative care, leading to varying practices and hospital stay lengths. The study explores whether removing chest tubes early and using a single-shot paravertebral block (PVB) for pain relief is as safe and effective as standard care, which uses longer chest tube duration and thoracic epidural analgesia (TEA). This randomized controlled trial is sponsored by Maxima Medical Center and aims to improve recovery quality and reduce hospital stays. Participants are divided into four groups comparing combinations of chest tube duration (early removal or at least 3 days) and pain management (TEA or single-shot PVB). The TEA involves placing an epidural catheter with local anesthetics and opioids for about 48 hours post-surgery. The single-shot PVB is administered at the start of surgery across ten levels with ropivacaine under thoracoscopic guidance. Chest tubes are connected to a Thopaz+ system with specific pressure settings, and removal criteria include patient alertness, absence of air leakage, clear chest X-ray, and no bloody drainage. During the study, participants will be monitored for chest tube drainage, pain levels from day 0 to 3, length of hospital stay, quality of recovery and life, postoperative complications, opioid use, mobility, health status, and patient satisfaction. Follow-up will continue for up to one year to assess pneumothorax recurrence and quality of life. The trial began in November 2023 and continues until November 2028, with no masking and randomized group assignments.

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