Lung NeoplasmsPhase 2NCT01703351
Prospective Randomized Trial Comparing the Effectiveness of Continuous Paravertebral Infusion of Local Anesthetics Versus Intravenous Patient-controlled Analgesia on Acute and Chronic Neuropathic Pain After VATS Lobectomy
A Phase 2 study testing 0.5% ropivacaine and Fentanyl 500mcg + acupan 160mg + nasea 0.6mg in people with Lung Neoplasms and Postoperative Pain, run by Yonsei University at 1 site in South Korea.
Trial summary
Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy and it has reduced the operative morbidities and mortalities. However, thoracoscopic lobectomy also results in operative acute pain and the incidence of chronic pain after thoracoscopic lobectomy has been reported as up to 50%. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Lung Neoplasms, Postoperative Pain
- What is being tested?
- 0.5% ropivacaine and Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Oct 2012to 6 Nov 2015
- Phase
- Phase 2
- 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 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age; 18≥, <75
- Thoracoscopic lobectomy due to lung cancer or suspected lung cancer
- Tolerable cardiopulmonary and other systemic function tolerable to lobectomy
- Karnofsky performance status ≥ 80
- Agree with study
Who cannot join
- Intolerable to one-lung ventilation
- Bleeding risk due to Aspirin, coumadin and other drugs
- Past or current history of depression or other psychiatric disease
- Pain persisted before operation due to lung lesion
- History of rib fracture, trauma or lung surgery at the same side of operation
- Severe pleural adhesion or empyema
Show all 11Show fewer
- Open thoracotomy conversion
- Reoperation due to postoperative bleeding or others
- Postoperative complications that need ICU care
- Chemical pleurodesis more than two times after operation
- Do not agree with study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
Seoul, 120-752
About this study
Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy and it has reduced the operative morbidities and mortalities. However, thoracoscopic lobectomy also results in operative acute pain and the incidence of chronic pain after thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar, torque at trocar and working window by operator, and compression of intercostal nerves have been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous patient-controlled analgesia (IV PCA) that usually have used to control the operative pain, sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might reduce the side effects of IV PCA and control the operative pain effectively. In this study, we investigate the effectiveness of continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.
- Conditions
- Lung Neoplasms, Postoperative Pain
- Being tested
- 0.5% ropivacaine, Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
- Keywords
- pain control, VATS
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% ropivacaineDrug
(n=48); continuous paravertebral infusion of local anesthetics (0.5% ropivacaine, 5cc/hr for 60 hours after operation) thorough catheter below the parietal pleura using On-Q® system(I-flow corp, Lake Forest, CA, USA)
Fentanyl 500mcg + acupan 160mg + nasea 0.6mgDrug
(n=48); IV PCA (Fentanyl 500mcg + acupan 160mg + nasea 0.6mg, 5cc/hr for 60 hours after operation, 0.5cc bolus if patients feel breakthrough pain)
| Study group | Role | What they receive |
|---|---|---|
| Drug: 0.5% ropivacaine | Experimental | Not described Receives: Drug: 0.5% ropivacaine |
| Fentanyl 500mcg + acupan 160mg + nasea 0.6mg | Active comparator | Not described Receives: Drug: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Acute pain
Measured: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)
Secondary outcomes (1)
2. Quality of life
Measured: measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study start4 Oct 2012
- Primary completion6 Nov 2015
- Study completion6 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703351
- Sponsor's protocol ID
- 4-2012-0470
- Status last verified
- Jan 2019
- First submitted
- 27 Sep 2012
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing the Effectiveness of Continuous Paravertebral Infusion of Local Anesthetics Versus Intravenous Patient-controlled Analgesia on Acute and Chronic Neuropathic Pain After VATS Lobectomy
- ClinicalTrials.gov ID
- NCT01703351
- Acronym / sponsor ID
- 4-2012-0470
- Conditions
- Lung Neoplasms, Postoperative Pain
- Keywords
- pain control, VATS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Oct 2012
- Primary completion
- 6 Nov 2015 (actual)
- Study completion
- 6 Nov 2015 (actual)
- First posted
- 10 Oct 2012 (estimated)
- 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.
Since mid-2000, thoracoscopic lobectomy has been replaced with conventional open lobectomy and it has reduced the operative morbidities and mortalities. However, thoracoscopic lobectomy also results in operative acute pain and the incidence of chronic pain after thoracoscopic lobectomy has been reported as up to 50%. Penetration of chest wall by trocar, torque at trocar and working window by operator, and compression of intercostal nerves have been suggested as a cause of pain after thoracoscopic lobectomy. The intravenous patient-controlled analgesia (IV PCA) that usually have used to control the operative pain, sometimes cause the side effects such as sedation, nausea and vomiting due to its systemic delivery of analgesics. Because of these side effects, IV PCA has to be discontinues and the effective dose of analgesics could not deliver to patients. In contrast to IV PCA, continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura might reduce the side effects of IV PCA and control the operative pain effectively. In this study, we investigate the effectiveness of continuous paravertebral infusion of local anesthetics thorough catheter below the parietal pleura for 60 hours after operation competed to IV PCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: 0.5% ropivacaine | Experimental | Drug: 0.5% ropivacaine |
| Fentanyl 500mcg + acupan 160mg + nasea 0.6mg | Active comparator | Drug: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age; 18≥, <75
- Thoracoscopic lobectomy due to lung cancer or suspected lung cancer
- Tolerable cardiopulmonary and other systemic function tolerable to lobectomy
- Karnofsky performance status ≥ 80
- Agree with study
Key exclusion criteria (11 listed)
- Intolerable to one-lung ventilation
- Bleeding risk due to Aspirin, coumadin and other drugs
- Past or current history of depression or other psychiatric disease
- Pain persisted before operation due to lung lesion
- History of rib fracture, trauma or lung surgery at the same side of operation
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 |
|---|---|---|
| 0.5% ropivacaine(n=48); continuous paravertebral infusion of local anesthetics (0.5% ropivacaine, 5cc/hr for 60 hours after operation) thorough catheter below the parietal pleura using On-Q® system(I-flow corp, Lake Forest, CA, USA) | Drug | Drug: 0.5% ropivacaine |
| Fentanyl 500mcg + acupan 160mg + nasea 0.6mg(n=48); IV PCA (Fentanyl 500mcg + acupan 160mg + nasea 0.6mg, 5cc/hr for 60 hours after operation, 0.5cc bolus if patients feel breakthrough pain) | Drug | Fentanyl 500mcg + acupan 160mg + nasea 0.6mg |
Primary outcome
1. Acute pain
Time frame: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)
1 secondary outcome
2. Quality of life
Time frame: measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation
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 31 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.5% ropivacaine and Fentanyl 500mcg + acupan 160mg + nasea 0.6mg in people with Lung Neoplasms and Postoperative Pain, run by Yonsei University at 1 site in South Korea.
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 11 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 31 Jan 2019. 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 South Korea. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
1. Acute pain (time frame: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)). 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 31 Jan 2019.