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

Not Applicable

Recruiting

• Conditions: VATS; Chest Tube Drainage; Pneumothorax, Primary Spontaneous; Pain, Postoperative; Locoregional Anaesthesia; Thoracic Epidural
• Interventions: Procedure: Thoracic epidural analgesia; Procedure: Single-shot paravertebral block; Procedure: Early chest tube removal; Procedure: Late chest tube removal

• Registration Number: NCT06053476
• Lead Sponsor: Maxima Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-25
• Study Start: 2023-11-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2028-02-01
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Early chest tube removal plus TEA	Early chest tube removal	-
Chest tube duration at least 3 days plus single-shot PVB	Late chest tube removal	-
Chest tube duration at least 3 days plus TEA	Thoracic epidural analgesia	-
Chest tube duration at least 3 days plus TEA	Late chest tube removal	-
Chest tube duration at least 3 days plus single-shot PVB	Single-shot paravertebral block	-
Early chest tube removal plus TEA	Thoracic epidural analgesia	-
Early chest tube removal plus single-shot PVB	Single-shot paravertebral block	-
Early chest tube removal plus single-shot PVB	Early chest tube removal	-

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay (LOS)	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.
Pain score	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.
Recurrence rate	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Recovery (QoR)	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)
Cumulative use of opioids and analgesics	postoperative day 0-4 and the use at 4 weeks follow-up	total opioid and non-opioid consumption as supplementary analgesic requirement
Health status	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.
Quality of Life (QoL)	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.
Postoperative complications	until 4 weeks follow-up	according to the Clavien-Dindo classification
Postoperative chest tube drainage during hospitalisation	30 postoperative days	Total number of postoperative days with a chest tube. The day of surgery is day 0.
degree of mobility	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)
patient satisfaction	postoperative day 0-4	5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied

Trial Locations

Locations (1)

Maxima MC; 🇳🇱 Veldhoven, Netherlands