Lung CancerNCT03228056
Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy
A study testing pain intensity measured in VAS scale in people with Lung Cancer, run by Pulmonary Hospital Zakopane at 2 sites in Poland.
Trial summary
This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- What is being tested?
- pain intensity measured in VAS scale
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jun 2016to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status 1-3
- undergo videothoracoscopic lung lobectomy
- forced expiratory volume in 1 second (FEV1) >1,5 l/min
- no contraindications for epidural anesthesia
- ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.
Who cannot join
- prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.
- during the study: failure to place epidural catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
Pulmonary Hospital
Zakopane, Malopolska, 34-500
Sylweriusz Kosiński, 602480289, kosa@mp.pl
- Recruiting
Pulmonary Hospital
Zakopane, 34-500
Sylweriusz Kosiński, 602480289, kosa@mp.pl
About this study
Official title: Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial
This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measure is cumulative morphine consumption up to 72 hours after surgery
Read the detailed description
The best VATS technique for lobectomy has not been well defined yet. Most of the authors describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the evolution of the technique is the use of a single-port approach. If conventional multiportal VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then further reduction in such access trauma should yield even greater benefits. Therefore, reducing the number of wounds from three or four to just one, should, in theory, lead to less pain, paresthesia, and morbidity as well as faster recovery. However, critics of the uniportal VATS approach may raise concerns about whether this most minimally invasive surgical approach for lung surgery may compromise safety and treatment efficacy. In addition, there's the concern about true invasiveness of the procedure. This prospective, randomized controlled trial was designed to compare the postoperative pain after VATS lobectomy performed through one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC) measured daily at the bedside up to 72 hours after surgery. All patients will receive the same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and complications including atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiratory depression and sedation will be analysed.
- Conditions
- Lung Cancer
- Being tested
- pain intensity measured in VAS scale
- Keywords
- postoperative pain, videothoracoscopic surgery, thoracic epidural analgesia, lung lobectomy
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain intensity measured in VAS scaleDiagnostic test
Pain intensity in 0-100 mm VAS scale is measured every 4 hours on standard ruler beginning from the end of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| uniportal VATS lobectomy | Experimental | * uniportal VATS lobectomy
* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
* ketoprofene 100 mg i.v every 12 hours
* paracetamol 1000 mg i.v every 8 hours
* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
* pain intensity measured in VAS scale Receives: Diagnostic Test: pain intensity measured in VAS scale |
| two-ports VATS lobectomy | Active comparator | * two-ports VATS lobectomy
* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
* ketoprofene 100 mg i.v every 12 hours
* paracetamol 1000 mg i.v every 8 hours
* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
* pain intensity measured in VAS scale Receives: Diagnostic Test: pain intensity measured in VAS scale |
| three-ports VATS lobectomy | Active comparator | * three-ports VATS lobectomy
* thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour)
* ketoprofene 100 mg i.v every 12 hours
* paracetamol 1000 mg i.v every 8 hours
* rescue doses of morphine in PCA system (bolus dose 2 mg i.v)
* pain intensity measured in VAS scale Receives: Diagnostic Test: pain intensity measured in VAS scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery
Measured: up to 72 hours after the end of surgery
Secondary outcomes (2)
opioid consumption
cumulative rescue morphine consumtion (PCA) in miligrams
Measured: up to 72 hours after the end of surgery
rate of complications
frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)
Measured: up to 72 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Jun 2016
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmonary Hospital Zakopane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcin Zieliński, PhD, Principal investigator, Pulmonary Hospital, Zakopane, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228056
- Sponsor's protocol ID
- PHZakopane
- Status last verified
- Apr 2018
- First submitted
- 9 Jun 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03228056
- Acronym / sponsor ID
- PHZakopane
- Conditions
- Lung Cancer
- Keywords
- postoperative pain, videothoracoscopic surgery, thoracic epidural analgesia, lung lobectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pulmonary Hospital ZakopaneUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 24 Jul 2017 (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.
This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measure is cumulative morphine consumption up to 72 hours after surgery
Detailed description
The best VATS technique for lobectomy has not been well defined yet. Most of the authors describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the evolution of the technique is the use of a single-port approach. If conventional multiportal VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then further reduction in such access trauma should yield even greater benefits. Therefore, reducing the number of wounds from three or four to just one, should, in theory, lead to less pain, paresthesia, and morbidity as well as faster recovery. However, critics of the uniportal VATS approach may raise concerns about whether this most minimally invasive surgical approach for lung surgery may compromise safety and treatment efficacy. In addition, there's the concern about true invasiveness of the procedure. This prospective, randomized controlled trial was designed to compare the postoperative pain after VATS lobectomy performed through one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC) measured daily at the bedside up to 72 hours after surgery. All patients will receive the same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and complications including atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiratory depression and sedation will be analysed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| uniportal VATS lobectomy | Experimental | Diagnostic Test: pain intensity measured in VAS scale* uniportal VATS lobectomy * thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour) * ketoprofene 100 mg i.v every 12 hours * paracetamol 1000 mg i.v every 8 hours * rescue doses of morphine in PCA system (bolus dose 2 mg i.v) * pain intensity measured in VAS scale |
| two-ports VATS lobectomy | Active comparator | Diagnostic Test: pain intensity measured in VAS scale* two-ports VATS lobectomy * thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour) * ketoprofene 100 mg i.v every 12 hours * paracetamol 1000 mg i.v every 8 hours * rescue doses of morphine in PCA system (bolus dose 2 mg i.v) * pain intensity measured in VAS scale |
| three-ports VATS lobectomy | Active comparator | Diagnostic Test: pain intensity measured in VAS scale* three-ports VATS lobectomy * thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour) * ketoprofene 100 mg i.v every 12 hours * paracetamol 1000 mg i.v every 8 hours * rescue doses of morphine in PCA system (bolus dose 2 mg i.v) * pain intensity measured in VAS scale |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists (ASA) physical status 1-3
- undergo videothoracoscopic lung lobectomy
- forced expiratory volume in 1 second (FEV1) >1,5 l/min
- no contraindications for epidural anesthesia
- ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.
Key exclusion criteria (2 listed)
- prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.
- during the study: failure to place epidural catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).
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 |
|---|---|---|
| pain intensity measured in VAS scalePain intensity in 0-100 mm VAS scale is measured every 4 hours on standard ruler beginning from the end of the surgery. | Diagnostic test | three-ports VATS lobectomy, two-ports VATS lobectomy, uniportal VATS lobectomy |
Primary outcome
pain intensity
Time frame: up to 72 hours after the end of surgery
0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery
2 secondary outcomes
opioid consumption
Time frame: up to 72 hours after the end of surgery
rate of complications
Time frame: up to 72 hours after the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Marcin Zieliński, PhD principal investigator
Pulmonary Hospital, Zakopane, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain intensity measured in VAS scale in people with Lung Cancer, run by Pulmonary Hospital Zakopane at 2 sites in Poland.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sylweriusz Kosiński, PhD (602480289, kosa@mp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: up to 72 hours after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2018.