Our objective is to compare the efficacy of early chest tube removal combined with single-shot PVB versus standard treatment (chest tube for at least 3 days and thoracic epidural analgesia (TEA)) after surgery for PSP. Efficacy is defined as proving…
ID
Source
Brief title
Condition
- Thoracic disorders (excl lung and pleura)
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This study encompasses two primary outcome measures:
1. Pain (non-inferiority): the proportion of NRS scores >=4, defined as the
number of NRS scores >=4 divided by the total number of NRS measurements
obtained during POD 0-3. A minimum of 11 NRS scores will be collected (1 at the
recovery room and 10 afterwards on the Ward).
2. Length of stay (days): total number of in-hospital days including
readmissions due to complications or recurrence within 30 days.
There is also a safety measure: absolute number of patients with recurrence
with a maximum difference of 9 recurrences. Recurrence is 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
1. Quality of recovery (QoR) using the QoR-15 questionnaire at baseline, POD
0-3 and at 4 weeks' follow-up
2. Quality of life (QoL) using the EORTC QLQ-C30 at baseline and at 4 weeks, 3
months and 1 year postoperatively
3. Number of postoperative days having a urinary catheter
4. Postoperative morbidity during the first 30 days or first hospital
admission, defined by the Clavien Dindo classification
5. Duration of postoperative chest tube drainage
6. Postoperative pain scores at rest and during mobilization/coughing during
POD 0-3 and at 4 weeks, 3 months and 1 year follow-up
7. Cumulative use of postoperative additional analgesics and opioids during
POD 0-3 and at 4 weeks follow-up
8. Daily degree of patient mobility (scale: in bed (1), in the chair (2), to
the toilet (3), outside the patient*s hospital room (4)) during POD 0-3
9. Health status scored by the EQ-5D tool at baseline, POD 0-3, after 1 month,
after 3 months and after 1 year follow-up
10. Patient satisfaction using the 5-point Likert scale during POD 0-3.
11. Cumulative use of additional chest X-rays and/or CT-scans (including
reason)
12. Cost-effectiveness and cost-utility from a health care perspective using
the Dutch Medical Consumption Questionnaire (DMCQ) and Productivity Cost
Questionnaire (PCQ), adjusted to the study setting, at 4 weeks, 3 months and 1
year postoperatively.
Background summary
Primary spontaneous pneumothorax (PSP) generally occurs in young males with an
incidence of 12.3 per 100,000 [Olesen 2019]. Guidelines recommend surgical
pleurodesis through video-assisted thoracoscopic surgery (VATS) in case of
recurrence after primarily conservative treatment [Henry 2003, Macduff 2010,
Tschopp 2015]. Recommendations on duration of postoperative chest tube drainage
and type of analgesia are however lacking. 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. Furuya however showed that chest tube
removal on the same day of surgery is safe and associated with a reduced length
of stay (LOS) [Furuya 2019]. Although thoracic epidural analgesia (TEA) is
considered the gold standard for pain management after thoracic surgery, the
use of VATS increases the interest in locoregional analgesia [Wildsmith 1989,
Batchelor 2019]. The guideline on enhanced recovery after thoracic surgery
suggests using locoregional analgesia to enhance mobilization and patient
satisfaction, whereas the more recent PROSPECT guideline even recommends
locoregional analgesia instead of TEA [Batchelor 2019, Feray 2022]. The
arguments are that locoregional analgesia provides sufficient analgesia without
epidural related side-effects, e.g. hypotension and urinary retention. Since
studies on locoregional analgesia in PSP are scarce, we performed a
retrospective study in Dutch hospitals to compare locoregional analgesia to
TEA, confirming adequate pain control and earlier mobilization [Spaans
submitted]. We furthermore performed a survey among Dutch thoracic surgeons
showing variety in PSP management [van Steenwijk 2023]. Our survey shows that
chest tubes are kept in place for a fixed number of days in 69% of respondents
and TEA is used for analgesia in 78%. Our hypothesis is that a progressive
policy with early chest tube removal and single-shot locoregional analgesia
decrease LOS, improve quality of recovery and quality of life and is more
cost-effective.
Study objective
Our objective is to compare the efficacy of early chest tube removal combined
with single-shot PVB versus standard treatment (chest tube for at least 3 days
and thoracic epidural analgesia (TEA)) after surgery for PSP. Efficacy is
defined as proving safety regarding recurrence and non-inferiority regarding
pain, and superiority regarding LOS.
Study design
An open-label, multicentre, four-arm randomized clinical trial using a 2x2
factorial design
Intervention
The Pneumotrial will study postoperative chest tube and pain management and
will encompass two interventions: 1. Early chest tube removal when the
following postoperative criteria are met: patietn is lucid and capable of
sitting up straight in bed, no air leakage for at least 4 hours or >=15mL/min
during at least 6 hours, postoperative X-ray (at least 4 hours after surgery)
demonstrating full lung expansion, absence of bloody drainage. 2. At the start
of surgery, before pleurodesis, a single-shot PVB will be placed at 10 thoracic
levels (T2-T11) with a total of 20mL local anesthetic in the paraertebral space
under direct thoracoscopic vision.
Study burden and risks
The overall potential risks are considered low since the intervention
strategies are already in use in some Dutch centres and have been demonstrated
feasible and safe in single centre studies. The additional burden for the
participants will be the completion of questionnaires. Regarding pain
management it is realistic to expect that patients treated with the
intervention single shot PVB will have more episodes of NRS >=4 and thus needing
more morphine to control the pain.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
Inclusion criteria
- Patients with primary spontaneous pneumothorax (PSP) and referred for surgery
due to recurrence, prolonged air leak (>=5 days), accompanied hemothorax or a
profession at risk (diving, polar explorers, working with compressed air). -
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.
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, lungfibrosis,
chronic obstructive pulmonary disease (COPD), active pneumonia, pulmonary
ipsilateral malignancy
- Contra-indications for thoracic epidural analgesia (TEA) (infection at skin
site, increased intracranial pressure, non-correctable coagulopathy, sepsis and
mechanical spine obstruction)
- Patients chronically 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84451.015.23 |