Postoperative PainNCT06425601
A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy
A study testing SIL drain and PVC drain in people with Postoperative Pain and Postoperative Complications, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Postoperative Complications
- What is being tested?
- SIL drain and PVC drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSlovenia
- Study dates
- 30 Sep 2020to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary lung cancer eligible for VATS lobectomy by tumor board meeting
Who cannot join
- age under 18 years
- high risk of post-operative complications (ASA > 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) < 15 ml/kg/min)
- tumors growing in parietal pleura
- extended lung resection diffuse
- previous surgery in the same hemithorax
- chronic pain
Show all 9Show fewer
- chronic use of analgesics or sedatives
- surgical revision
- inability to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains
The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.
The main questions it aims to answer are:
- silicone chest drains are less painful compared to standard PVC drains?
- is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.
- Conditions
- Postoperative Pain, Postoperative Complications
- Being tested
- SIL drain, PVC drain
- Keywords
- VATS, lung lobectomy, postoperative pain, chest drain, analgesia
- Medical subject headings
- Pain, Postoperative, Postoperative Complications, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIL drainDevice
Silicone chest tube used for pleural space drainage after VATS lobectomy
PVC drainDevice
Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy
| Study group | Role | What they receive |
|---|---|---|
| Silicone (SIL) group | Experimental | For postoperative pleural space drainage a silicone coaxial drain of size French 24 (Redax Coaxial Drain, Redax S.p.A., Poggio Rusco Mantova, Italy) was used Receives: Device: SIL drain |
| PVC group | Active comparator | For postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used Receives: Device: PVC drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesics consumption
Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome.
Measured: 2 days
Need for peroral analgesia after the chest tube removal
Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome.
Measured: 2 days
Maximal inspiratory pressure
Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome.
Measured: 2 days
Maximal expiratory pressure
Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome.
Measured: 2 days
Visual analogue scale
Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome.
Measured: 2 days
Secondary outcomes (11)
Duration of chest drainage
The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome.
Measured: 1 month
Pneumothorax rate on the day of surgery
The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.
Measured: First day
Pneumothorax rate after chest tube removal
The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.
Measured: 1 month
Pleural effusion rate on the day of surgery
The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.
Measured: First day
Pleural effusion rate after chest tube removal
The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome.
Measured: 1 month
Subcutaneous emphysema rate
The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome.
Measured: 1 month
Prolonged air leak rate
The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome.
Measured: 1 month
Reintervention rate
The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome.
Measured: 1 month
Duration of hospital stay
Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome.
Measured: 1 month
Respiratory complication rate
Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome.
Measured: 1 month
Readmission rate
Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start30 Sep 2020
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris Greif, MD, University Medical Centre Ljubljana
- Investigators
- Boris Greif, Principal investigator, UMC Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425601
- Sponsor's protocol ID
- 0120-445/2019/8
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Greif B, Zgajnar J, Stupnik T. Impact of chest tube type on pain, drainage efficacy, and short-term treatment outcome following video-assisted thoracoscopic surgery lobectomy: a randomized controlled trial comparing coaxial silicone drains and standard polyvinyl chloride drains. J Thorac Dis. 2025 Feb 28;17(2):932-943. doi: 10.21037/jtd-24-1489. Epub 2025 Feb 21.
PubMed 40083488
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chest Drain Type on Pain, Drainage Efficacy and Short Term Outcome Following VATS Lobectomy for Lung Cancer: A Prospective Randomized Study Comparing Silicone Versus PVC Drains
- ClinicalTrials.gov ID
- NCT06425601
- Acronym / sponsor ID
- 0120-445/2019/8
- Conditions
- Postoperative Pain, Postoperative Complications
- Keywords
- VATS, lung lobectomy, postoperative pain, chest drain, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.
The main questions it aims to answer are:
- silicone chest drains are less painful compared to standard PVC drains?
- is there any difference in chest drainage efficacy and short term outcome between the two groups? Researchers will compare silicone chest drain group with PVC chest drain group to see if there is any difference in postoperative pain, chest drainage efficacy and short term outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silicone (SIL) group | Experimental | Device: SIL drainFor postoperative pleural space drainage a silicone coaxial drain of size French 24 (Redax Coaxial Drain, Redax S.p.A., Poggio Rusco Mantova, Italy) was used |
| PVC group | Active comparator | Device: PVC drainFor postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary lung cancer eligible for VATS lobectomy by tumor board meeting
Key exclusion criteria (9 listed)
- age under 18 years
- high risk of post-operative complications (ASA > 3, diffusion capacity for transfer factor (TLCO) or forced expiratory volume at one second (FEV1) ≤ 40%, cycle ergometry with oxygen consumption (VO2 max) < 15 ml/kg/min)
- tumors growing in parietal pleura
- extended lung resection diffuse
- previous surgery in the same hemithorax
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIL drainSilicone chest tube used for pleural space drainage after VATS lobectomy | Device | Silicone (SIL) group |
| PVC drainPolyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy | Device | PVC group |
Primary outcome
Analgesics consumption
Time frame: 2 days
Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome.
Need for peroral analgesia after the chest tube removal
Time frame: 2 days
Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome.
Maximal inspiratory pressure
Time frame: 2 days
Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome.
Maximal expiratory pressure
Time frame: 2 days
Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome.
Visual analogue scale
Time frame: 2 days
Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome.
11 secondary outcomes
Duration of chest drainage
Time frame: 1 month
Pneumothorax rate on the day of surgery
Time frame: First day
Pneumothorax rate after chest tube removal
Time frame: 1 month
Pleural effusion rate on the day of surgery
Time frame: First day
Pleural effusion rate after chest tube removal
Time frame: 1 month
Subcutaneous emphysema rate
Time frame: 1 month
Prolonged air leak rate
Time frame: 1 month
Reintervention rate
Time frame: 1 month
Duration of hospital stay
Time frame: 1 month
Respiratory complication rate
Time frame: 1 month
Readmission rate
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Derived from this study: PubMed 40083488Greif B, Zgajnar J, Stupnik T. Impact of chest tube type on pain, drainage efficacy, and short-term treatment outcome following video-assisted thoracoscopic surgery lobectomy: a randomized controlled trial comparing coaxial silicone drains and standard polyvinyl chloride drains. J Thorac Dis. 2025 Feb 28;17(2):932-943. doi: 10.21037/jtd-24-1489. Epub 2025 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Greif principal investigator
UMC Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIL drain and PVC drain in people with Postoperative Pain and Postoperative Complications, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesics consumption (time frame: 2 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06425601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.