Collapsed lung, Pneumothorax
Conditions
Interventions
 
The Pneumotrial will study postoperative chest tube and pain management and 
will encompass two interventions: 1. Early chest tube removal when the 
following postoperative criteria are met: patietn is lucid and capable of 
sitting up straight in bed, no air leakage for at least 4 hours or >
=15mL/min 
during at least 6 hours, postoperative X-ray (at least 4 hours after surgery) 
demonstrating full lung expansion, absence of bloody drainage. 2. At the start 
of surgery, before pleurodesis, a single-shot PVB will be placed at 10 thoracic 
levels (T2-T11) with a total of 20mL local anesthetic in the paraertebral space 
under direct thoracoscopic vision. 
Sponsors
Máxima MC
Eligibility
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with primary spontaneous pneumothorax (PSP) (both clear-cut PSP and inconclusive SP) and referred for surgery due to recurrence, prolonged air leak (>=5 days), accompanied hemothorax or a profession at risk (diving, polar explorers, working with compressed air). - Age >= 16 years - Able to read and understand the Dutch language - Mentally able to provide informed consent - Patients should preferably 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.
Exclusion criteria
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, lungfibrosis, active pneumonia, pulmonary ipsilateral malignancy- Patients with extensive bullous lung emphysema detected on CT scan and treated by a pulmonologist for chronic obstructive pulmonary disease (COPD) orstandard treatment (pleurodesis with bullectomy) is not possible - Contra-indications for thoracic epidural analgesia (TEA) (infection at skin site, increased intracranial pressure, non-correctable coagulopathy, sepsis and mechanical spine obstruction) - Patients chronically 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study encompasses two primary outcome measures: 1. Pain (non-inferiority): the proportion of NRS scores >=4, defined as the number of NRS scores >=4 divided by the total number of NRS measurements obtained during POD 0-3. A minimum of 11 NRS scores will be collected (1 at the recovery room and 10 afterwards on the Ward). 2. Length of stay (days): total number of in-hospital days including readmissions due to complications or recurrence within 30 days. There is also a safety measure: absolute number of patients with recurrence with a maximum difference of 9 recurrences. Recurrence is 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of recovery (QoR) using the QoR-15 questionnaire at baseline, POD 0-3 and at 4 weeks' follow-up 2. Quality of life (QoL) using the EORTC QLQ-C30 at baseline and at 4 weeks, 3 months and 1 year postoperatively 3. Number of postoperative days having a urinary catheter 4. Postoperative morbidity during the first 30 days or first hospital admission, defined by the Clavien Dindo classification 5. Duration of postoperative chest tube drainage 6. Postoperative pain scores at rest and during mobilization/coughing during POD 0-3 and at 4 weeks, 3 months and 1 year follow-up 7. Cumulative use of postoperative additional analgesics and opioids during POD 0-3 and at 4 weeks follow-up 8. Daily degree of patient mobility (scale: in bed (1), in the chair (2), to the toilet (3), outside the patient*s hospital room (4)) during POD 0-3 9. Health status scored by the EQ-5D tool at baseline, POD 0-3, after 1 month, after 3 months and after 1 year follow-up 10. Patient satisfaction using the 5-point Likert scale during POD 0-3. 11. Cumulative use of additional chest X-rays and/or CT-scans (including reason) 12. Cost-effectiveness and cost-utility from a health care perspective using the Dutch Medical Consumption Questionnaire (DMCQ) and Productivity Cost Questionnaire (PCQ), adjusted to the study setting, at 4 weeks, 3 months and 1 year postoperatively. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactQCA Steenwijk
Máxima MC
Outcome results
None listed