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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01703351
Recruitment Status : Unknown
Verified January 2016 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : October 10, 2012
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
Yonsei University

Brief 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%. 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.

Condition or disease Intervention/treatment Phase
Lung Cancer, Postoperative Pain Drug: 0.5% ropivacaine Drug: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : October 2012
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fentanyl
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Drug: 0.5% ropivacaine 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 Drug: 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)

Primary Outcome Measures :
  1. 1. Acute pain [ Time Frame: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4) ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 3. Neuropathic pain [ Time Frame: VAS score and dose of analgesics in 4, 12 weeks after operation ]

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01703351

Contact: Dae Joon Kim, MD 82-2-2228-2141

Korea, Republic of
Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Dae Joon Kim, MD    +82-2-2228-2141   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT01703351     History of Changes
Other Study ID Numbers: 4-2012-0470
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016

Keywords provided by Yonsei University:
pain control, VATS

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Autonomic Agents
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action