Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
1 other identifier
interventional
366
1 country
1
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2023
CompletedFirst Posted
Study publicly available on registry
September 25, 2023
CompletedStudy Start
First participant enrolled
November 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
May 9, 2025
May 1, 2025
4.2 years
September 12, 2023
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (8)
Quality of Recovery (QoR)
until 4 weeks 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
Cumulative use of opioids and analgesics
postoperative day 0-4 and the use at 4 weeks follow-up
- +3 more secondary outcomes
Study Arms (4)
Chest tube duration at least 3 days plus TEA
ACTIVE COMPARATORChest tube duration at least 3 days plus single-shot PVB
EXPERIMENTALEarly chest tube removal plus TEA
EXPERIMENTALEarly chest tube removal plus single-shot PVB
EXPERIMENTALInterventions
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).
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.
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
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maxima MC
Veldhoven, 5504 DB, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Coordinating Investigator, MD
Study Record Dates
First Submitted
September 12, 2023
First Posted
September 25, 2023
Study Start
November 8, 2023
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
May 9, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
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.