- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01703351
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
January 29, 2019 updated by: Yonsei University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 120-752
- Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug: 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)
|
Active Comparator: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
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(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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. Acute pain
Time Frame: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)
|
Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
3. Neuropathic pain
Time Frame: VAS score and dose of analgesics in 4, 12 weeks after operation
|
VAS score and dose of analgesics in 4, 12 weeks after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 4, 2012
Primary Completion (Actual)
November 6, 2015
Study Completion (Actual)
November 6, 2015
Study Registration Dates
First Submitted
September 27, 2012
First Submitted That Met QC Criteria
October 7, 2012
First Posted (Estimate)
October 10, 2012
Study Record Updates
Last Update Posted (Actual)
January 31, 2019
Last Update Submitted That Met QC Criteria
January 29, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Ropivacaine
Other Study ID Numbers
- 4-2012-0470
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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