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NCT Number: NCT06053476

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

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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Key information

Conditions

Pneumothorax, Primary Spontaneous Chest Tube Drainage Locoregional Anaesthesia Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pneumothorax Postoperative Complications Respiratory Tract Diseases Signs and Symptoms Thoracic Epidural VATS

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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:

  • 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 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:

  • 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Quality of Recovery (QoR)

    Time frame: until 4 weeks follow-up

    QoR measured with the QoR-15 questionnaire on postoperative 1 and 2 (maximum score of 150, the higher the score the better the outcome)

  2. Quality of Life (QoL)

    Time frame: until 1 year follow-up

    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.

  3. Postoperative complications

    Time frame: until 4 weeks follow-up

    according to the Clavien-Dindo classification

  4. Postoperative chest tube drainage during hospitalisation

    Time frame: 30 postoperative days

    Total number of postoperative days with a chest tube. The day of surgery is day 0.

  5. Cumulative use of opioids and analgesics

    Time frame: postoperative day 0-4 and the use at 4 weeks follow-up

    total opioid and non-opioid consumption as supplementary analgesic requirement

  6. degree of mobility

    Time frame: postoperative day 0-4

    4-point scale: on the bed (1), to the chair (2), to the toilet (3), outside the patient's hospital room(4)

  7. Health status

    Time frame: until 1 year follow-up

    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.

  8. patient satisfaction

    Time frame: postoperative day 0-4

    5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied

Study contacts

Contact information is provided by the study sponsor or research team.

Frank J.C. van den Broek, MD, PhD

CONTACT

[email protected]

+31-40888-8550

Quirine C.A. van Steenwijk, MD

CONTACT

[email protected]

+31-40888-7243

Sponsors and collaborators

Lead sponsor

Maxima Medical Center

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Leiden University Medical Center
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial); a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 25, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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