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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Leiden University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest tube duration at least 3 days plus TEA | Active Comparator |
| |
| Chest tube duration at least 3 days plus single-shot PVB | Experimental |
| |
| Early chest tube removal plus TEA | Experimental |
| |
| Early chest tube removal plus single-shot PVB | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic epidural analgesia | Procedure | After correct placement of the epidural catheter, a local anaesthetic (ropivacaine, levobupivacaine or bupivacaine) will be started and, according to in house protocols, an opioid will be added to the epidural solution. A provisional stop of the administration of the epidural infusion is planned after 48 hours (on the second postoperative day). |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | 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. | Until 1 year follow-up |
| Pain score | 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. | Postoperative day 0-3 |
| Postoperative length of stay (LOS) | 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. | 30 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery (QoR) | QoR measured with the QoR-15 questionnaire on postoperative 1 and 2 (maximum score of 150, the higher the score the better the outcome) | until 4 weeks follow-up |
| Quality of Life (QoL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quirine C.A. van Steenwijk, MD | Contact | +31-40888-7243 | quirine.van.steenwijk@mmc.nl | |
| Frank J.C. van den Broek, MD, PhD | Contact | +31-40888-8550 | frankvanden.broek@mmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maxima MC | Recruiting | Veldhoven | 5504 DB | Netherlands |
Data will become available for non-commercial scientific research (open access) after a period of 12 months after the last data collection. Data request can be done by contacting the PI.
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|
| Single-shot paravertebral block | Procedure | At the beginning of surgery, before pleurectomy, a single shot PVB will be placed at 10 levels (T2-T11) by the surgeon with Ropivacaine 7.5mg/mL and 2-3mL per site under direct thoracoscopic vision. The injection site will be chosen at the paravertebral space, just lateral adjacent to the sympathetic trunk. |
|
| Late chest tube removal | Procedure | Postoperatively, the chest tube is connected to a Thopaz+ system (Medela inc.) and installed to -2 or -5 cm H2O. The chest tube will be left in place during a fixed period of 3 postoperative days. The chest tube will be removed at the earliest at POD 3 in case the following criteria are met:
|
|
| Early chest tube removal | Procedure | Postoperatively, the chest tube is connected to a Thopaz+ system (Medela inc.) and installed to -2 or -5 cm H2O. The chest tube will be removed at the earliest at 4 hours postoperatively in case the following criteria are met:
|
|
QoL will be measured using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). This 33-item questionnaire incorporates functional scales, symptom scales and overall health status. The scale range from 0 to 100; a higher score represents a higher response level.
| until 1 year follow-up |
| Postoperative complications | according to the Clavien-Dindo classification | until 4 weeks follow-up |
| Postoperative chest tube drainage during hospitalisation | Total number of postoperative days with a chest tube. The day of surgery is day 0. | 30 postoperative days |
| Cumulative use of opioids and analgesics | total opioid and non-opioid consumption as supplementary analgesic requirement | postoperative day 0-4 and the use at 4 weeks follow-up |
| degree of mobility | 4-point scale: on the bed (1), to the chair (2), to the toilet (3), outside the patient's hospital room(4) | postoperative day 0-4 |
| Health status | Health status will we measured using the EuroQol-5D (EQ-5D) tool. This tool incorporates 5 aspects regarding health. The scale range from 0 to 100; a higher score represents a higher health status. | until 1 year follow-up |
| patient satisfaction | 5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied | postoperative day 0-4 |
| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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