Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
NCT ID: NCT06053476
Last Updated: 2025-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
366 participants
INTERVENTIONAL
2023-11-08
2028-11-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Chest tube duration at least 3 days plus TEA
Thoracic epidural analgesia
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).
Late chest tube removal
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:
1. The patient is lucid and capable of sitting up straight in bed on his/her own
2. No air leakage indicated by the Thopaz+ system during at least 4 hours, or \<15 mL/min air leakage during at least 6 hours
3. Postoperative X ray (performed at least 4 hours after surgery or ultimately performed the morning of POD1) demonstrating complete lung expansion at the level of the hilum.
4. Absence of bloody drainage by the Thopaz+ system
Chest tube duration at least 3 days plus single-shot PVB
Single-shot paravertebral block
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
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:
1. The patient is lucid and capable of sitting up straight in bed on his/her own
2. No air leakage indicated by the Thopaz+ system during at least 4 hours, or \<15 mL/min air leakage during at least 6 hours
3. Postoperative X ray (performed at least 4 hours after surgery or ultimately performed the morning of POD1) demonstrating complete lung expansion at the level of the hilum.
4. Absence of bloody drainage by the Thopaz+ system
Early chest tube removal plus TEA
Thoracic epidural analgesia
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).
Early chest tube removal
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:
1. The patient is lucid and capable of sitting up straight in bed on his/her own
2. No air leakage indicated by the Thopaz+ system during at least 4 hours, or \<15 mL/min air leakage during at least 6 hours
3. Postoperative X ray (performed at least 4 hours after surgery or ultimately performed the morning of POD1) demonstrating complete lung expansion at the level of the hilum.
4. Absence of pure blood drainage by the Thopaz+ system
Early chest tube removal plus single-shot PVB
Single-shot paravertebral block
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.
Early chest tube removal
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:
1. The patient is lucid and capable of sitting up straight in bed on his/her own
2. No air leakage indicated by the Thopaz+ system during at least 4 hours, or \<15 mL/min air leakage during at least 6 hours
3. Postoperative X ray (performed at least 4 hours after surgery or ultimately performed the morning of POD1) demonstrating complete lung expansion at the level of the hilum.
4. Absence of pure blood drainage by the Thopaz+ system
Interventions
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Thoracic epidural analgesia
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).
Single-shot paravertebral block
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
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:
1. The patient is lucid and capable of sitting up straight in bed on his/her own
2. No air leakage indicated by the Thopaz+ system during at least 4 hours, or \<15 mL/min air leakage during at least 6 hours
3. Postoperative X ray (performed at least 4 hours after surgery or ultimately performed the morning of POD1) demonstrating complete lung expansion at the level of the hilum.
4. Absence of bloody drainage by the Thopaz+ system
Early chest tube removal
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:
1. The patient is lucid and capable of sitting up straight in bed on his/her own
2. No air leakage indicated by the Thopaz+ system during at least 4 hours, or \<15 mL/min air leakage during at least 6 hours
3. Postoperative X ray (performed at least 4 hours after surgery or ultimately performed the morning of POD1) demonstrating complete lung expansion at the level of the hilum.
4. Absence of pure blood drainage by the Thopaz+ system
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Leiden University Medical Center
OTHER
Maxima Medical Center
OTHER
Responsible Party
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Quirine van Steenwijk
Coordinating Investigator, MD
Locations
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Maxima MC
Veldhoven, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL84451.015.23
Identifier Type: -
Identifier Source: org_study_id
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