Pneumothorax, Primary SpontaneousNCT06053476
Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
A study testing Thoracic epidural analgesia, Single-shot paravertebral block and Late chest tube removal in people with Pneumothorax, Primary Spontaneous and VATS, run by Maxima Medical Center at 1 site in Netherlands.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pneumothorax, Primary Spontaneous, VATS, Pain, Postoperative
- What is being tested?
- Thoracic epidural analgesia, Single-shot paravertebral block and Late chest tube removal
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Nov 2023to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maxima MC
Veldhoven, 5504 DB
Quirine C.A. van Steenwijk, MD, +31408887243, quirine.van.steenwijk@mmc.nl
Frank J.C. van den Broek, MD, PhD, +31408888550, frankvanden.broek@mmc.nl
About this study
Official title: Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Pneumothorax, Primary Spontaneous, VATS, Pain, Postoperative, Locoregional Anaesthesia, Thoracic Epidural, Chest Tube Drainage
- Being tested
- Thoracic epidural analgesia, Single-shot paravertebral block, Late chest tube removal, Early chest tube removal
- Medical subject headings
- Pneumothorax, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural analgesiaProcedure or surgery
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 blockProcedure or surgery
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 removalProcedure or surgery
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:
- The patient is lucid and capable of sitting up straight in bed on his/her own
- No air leakage indicated by the Thopaz+ system during at least 4 hours, or <15 mL/min air leakage during at least 6 hours
- 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.
- Absence of bloody drainage by the Thopaz+ system
Early chest tube removalProcedure or surgery
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:
- The patient is lucid and capable of sitting up straight in bed on his/her own
- No air leakage indicated by the Thopaz+ system during at least 4 hours, or <15 mL/min air leakage during at least 6 hours
- 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.
- Absence of pure blood drainage by the Thopaz+ system
| Study group | Role | What they receive |
|---|---|---|
| Chest tube duration at least 3 days plus TEA | Active comparator | Not described Receives: Procedure: Thoracic epidural analgesia; Procedure: Late chest tube removal |
| Chest tube duration at least 3 days plus single-shot PVB | Experimental | Not described Receives: Procedure: Single-shot paravertebral block; Procedure: Late chest tube removal |
| Early chest tube removal plus TEA | Experimental | Not described Receives: Procedure: Thoracic epidural analgesia; Procedure: Early chest tube removal |
| Early chest tube removal plus single-shot PVB | Experimental | Not described Receives: Procedure: Single-shot paravertebral block; Procedure: Early chest tube removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 30 postoperative days
Secondary outcomes (8)
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)
Measured: until 4 weeks follow-up
Quality of Life (QoL)
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.
Measured: until 1 year follow-up
Postoperative complications
according to the Clavien-Dindo classification
Measured: 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.
Measured: 30 postoperative days
Cumulative use of opioids and analgesics
total opioid and non-opioid consumption as supplementary analgesic requirement
Measured: 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)
Measured: 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.
Measured: until 1 year follow-up
patient satisfaction
5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied
Measured: postoperative day 0-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start8 Nov 2023
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumothorax, Primary SpontaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxima Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Leiden University Medical Center
- Responsible party
- Principal investigator, Quirine van Steenwijk, Maxima Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053476
- Sponsor's protocol ID
- NL84451.015.23
- Status last verified
- May 2025
- First submitted
- 12 Sep 2023
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06053476
- Acronym / sponsor ID
- NL84451.015.23
- Conditions
- Pneumothorax, Primary Spontaneous, VATS, Pain, Postoperative, Locoregional Anaesthesia, Thoracic Epidural, Chest Tube Drainage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Maxima Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Leiden University Medical Center
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chest tube duration at least 3 days plus TEA | Active comparator | Procedure: Thoracic epidural analgesia, Procedure: Late chest tube removal |
| Chest tube duration at least 3 days plus single-shot PVB | Experimental | Procedure: Single-shot paravertebral block, Procedure: Late chest tube removal |
| Early chest tube removal plus TEA | Experimental | Procedure: Thoracic epidural analgesia, Procedure: Early chest tube removal |
| Early chest tube removal plus single-shot PVB | Experimental | Procedure: Single-shot paravertebral block, Procedure: Early chest tube removal |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic epidural analgesiaAfter 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). | Procedure or surgery | Chest tube duration at least 3 days plus TEA, Early chest tube removal plus TEA |
| Single-shot paravertebral blockAt 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. | Procedure or surgery | Chest tube duration at least 3 days plus single-shot PVB, Early chest tube removal plus single-shot PVB |
| Late chest tube removalPostoperatively, 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 | Procedure or surgery | Chest tube duration at least 3 days plus TEA, Chest tube duration at least 3 days plus single-shot PVB |
| Early chest tube removalPostoperatively, 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 | Procedure or surgery | Early chest tube removal plus TEA, Early chest tube removal plus single-shot PVB |
Primary outcome
Recurrence rate
Time frame: 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.
Pain score
Time frame: 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.
Postoperative length of stay (LOS)
Time frame: 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.
8 secondary outcomes
Quality of Recovery (QoR)
Time frame: until 4 weeks follow-up
Quality of Life (QoL)
Time frame: until 1 year follow-up
Postoperative complications
Time frame: until 4 weeks follow-up
Postoperative chest tube drainage during hospitalisation
Time frame: 30 postoperative days
Cumulative use of opioids and analgesics
Time frame: postoperative day 0-4 and the use at 4 weeks follow-up
degree of mobility
Time frame: postoperative day 0-4
Health status
Time frame: until 1 year follow-up
patient satisfaction
Time frame: postoperative day 0-4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic epidural analgesia, Single-shot paravertebral block and Late chest tube removal in people with Pneumothorax, Primary Spontaneous and VATS, run by Maxima Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quirine C.A. van Steenwijk, MD (+31-40888-7243, quirine.van.steenwijk@mmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: Until 1 year follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.