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

NCT ID: NCT01703351

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-04
• Study Completion Date: 2015-11-06

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.

Conditions

Lung Neoplasms; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Drug: 0.5% ropivacaine

Group Type: EXPERIMENTAL

0.5% ropivacaine

Intervention Type: DRUG

(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 0.6mg

Group Type: ACTIVE_COMPARATOR

Fentanyl 500mcg + acupan 160mg + nasea 0.6mg

Intervention Type: DRUG

(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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2012-0470

Identifier Type: -

Identifier Source: org_study_id