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

Overview

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.

Interventions

• Procedure 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).
• Procedure 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.
• Procedure 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 hour
• Procedure 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

Primary outcome measures

• Recurrence rate [Time frame: Until 1 year follow-up]
• Pain score [Time frame: Postoperative day 0-3]
• Postoperative length of stay (LOS) [Time frame: 30 postoperative days]

Secondary outcome measures (8)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Factorial

Masking

Open label

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Maxima MC — Veldhoven

Identifiers

NCT: NCT06053476 · NL84451.015.23

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗