Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 366
- 试验地点
- 2
- 主要终点
- Postoperative length of stay (LOS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Postoperative length of stay (LOS)
时间窗: 30 postoperative days
the total number of in-hospital days including readmissions due to complications or recurrence within 30 postoperative days (POD). The day of surgery will be POD 0.
Pain score
时间窗: Postoperative day 0-3
Proportion of pain scores ≥4 as assessed by the numerical rating scale (NRS), defined as the number of NRS scores ≥4 divided by the total number of NRS measurements. NRS score is measured from 0 until 10; lowest value signifying no pain and highest value signifying worst pain.
Recurrence rate
时间窗: Until 1 year follow-up
Safety outcome: absolute number of patients with recurrence (maximum allowable difference between early and late chest tube removal groups of 9 recurrences) defined as having an ipsilateral recurrent pneumothorax after chest tube removal, confirmed by X-ray or CT within 1-year, requiring reintervention (either tube thoracostomy or reoperation) or hospital readmission.
次要结局
- Quality of Recovery (QoR)(until 4 weeks follow-up)
- Cumulative use of opioids and analgesics(postoperative day 0-4 and the use at 4 weeks follow-up)
- Health status(until 1 year follow-up)
- Quality of Life (QoL)(until 1 year follow-up)
- Postoperative complications(until 4 weeks follow-up)
- Postoperative chest tube drainage during hospitalisation(30 postoperative days)
- degree of mobility(postoperative day 0-4)
- patient satisfaction(postoperative day 0-4)
研究者
Quirine van Steenwijk
Coordinating Investigator, MD
Maxima Medical Center