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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01703351
First received: September 27, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • 1. Acute pain [ Time Frame: Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 3. Neuropathic pain [ Time Frame: VAS score and dose of analgesics in 4, 12 weeks after operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703351

Contacts
Contact: Dae Joon Kim, MD 82-2-2228-2141 kdjcool@yuhs.ac

Locations
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    kdjcool@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01703351     History of Changes
Other Study ID Numbers: 4-2012-0470
Study First Received: September 27, 2012
Last Updated: December 4, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Yonsei University:
pain control, VATS

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Anesthetics, Local
Fentanyl
Ropivacaine
Adjuvants, Anesthesia
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014