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Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)

Primary Purpose

Pneumothorax, Primary Spontaneous, VATS, Pain, Postoperative

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thoracic epidural analgesia
Single-shot paravertebral block
Late chest tube removal
Early chest tube removal
Sponsored by
Maxima Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax, Primary Spontaneous

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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, 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Chest tube duration at least 3 days plus TEA

    Chest tube duration at least 3 days plus single-shot PVB

    Early chest tube removal plus TEA

    Early chest tube removal plus single-shot PVB

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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 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.

    Secondary Outcome Measures

    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)
    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.
    Postoperative complications
    according to the Clavien-Dindo classification
    Postoperative chest tube drainage during hospitalisation
    Total number of postoperative days with a chest tube. The day of surgery is day 0.
    Cumulative use of opioids and analgesics
    total opioid and non-opioid consumption as supplementary analgesic requirement
    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)
    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.
    patient satisfaction
    5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied

    Full Information

    First Posted
    September 12, 2023
    Last Updated
    September 22, 2023
    Sponsor
    Maxima Medical Center
    Collaborators
    ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Leiden University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06053476
    Brief Title
    Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)
    Official Title
    Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    February 1, 2028 (Anticipated)
    Study Completion Date
    November 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maxima Medical Center
    Collaborators
    ZonMw: The Netherlands Organisation for Health Research and Development, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Leiden University Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pneumothorax, Primary Spontaneous, VATS, Pain, Postoperative, Locoregional Anaesthesia, Thoracic Epidural, Chest Tube Drainage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    366 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chest tube duration at least 3 days plus TEA
    Arm Type
    Active Comparator
    Arm Title
    Chest tube duration at least 3 days plus single-shot PVB
    Arm Type
    Experimental
    Arm Title
    Early chest tube removal plus TEA
    Arm Type
    Experimental
    Arm Title
    Early chest tube removal plus single-shot PVB
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Thoracic epidural analgesia
    Intervention Description
    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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Single-shot paravertebral block
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Late chest tube removal
    Intervention Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Early chest tube removal
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Recurrence rate
    Description
    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.
    Time Frame
    Until 1 year follow-up
    Title
    Pain score
    Description
    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.
    Time Frame
    Postoperative day 0-3
    Title
    Postoperative length of stay (LOS)
    Description
    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.
    Time Frame
    30 postoperative days
    Secondary Outcome Measure Information:
    Title
    Quality of Recovery (QoR)
    Description
    QoR measured with the QoR-15 questionnaire on postoperative 1 and 2 (maximum score of 150, the higher the score the better the outcome)
    Time Frame
    until 4 weeks follow-up
    Title
    Quality of Life (QoL)
    Description
    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.
    Time Frame
    until 1 year follow-up
    Title
    Postoperative complications
    Description
    according to the Clavien-Dindo classification
    Time Frame
    until 4 weeks follow-up
    Title
    Postoperative chest tube drainage during hospitalisation
    Description
    Total number of postoperative days with a chest tube. The day of surgery is day 0.
    Time Frame
    30 postoperative days
    Title
    Cumulative use of opioids and analgesics
    Description
    total opioid and non-opioid consumption as supplementary analgesic requirement
    Time Frame
    postoperative day 0-4 and the use at 4 weeks follow-up
    Title
    degree of mobility
    Description
    4-point scale: on the bed (1), to the chair (2), to the toilet (3), outside the patient's hospital room(4)
    Time Frame
    postoperative day 0-4
    Title
    Health status
    Description
    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.
    Time Frame
    until 1 year follow-up
    Title
    patient satisfaction
    Description
    5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied
    Time Frame
    postoperative day 0-4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. 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, 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Quirine C.A. van Steenwijk, MD
    Phone
    +31-40888-8550
    Email
    quirine.van.steenwijk@mmc.nl
    First Name & Middle Initial & Last Name or Official Title & Degree
    Frank J.C. van den Broek, MD, PhD
    Phone
    +31-40888-8550
    Email
    frankvanden.broek@mmc.nl

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.

    Learn more about this trial

    Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)

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