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

Study Overview
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Brief Summary
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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
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Lung Neoplasms, Postoperative Pain

Intervention / Treatment
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* Drug: 0.5% ropivacaine
* Drug: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug: 0.5% ropivacaine<br> | Drug: 0.5% ropivacaine<br>* (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)<br>|
| Active Comparator: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg<br> | Drug: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg<br>* (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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Acute pain |  | Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Quality of life |  | measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain control, VATS