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

Phase 2

Completed

• Conditions: Lung Neoplasms; Postoperative Pain
• Interventions: Drug: 0.5% ropivacaine; Drug: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg

• Registration Number: NCT01703351
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-27
• Study Start: 2012-10-04
• Study First Submitted QC: 2012-10-07
• Study First Posted: 2012-10-10
• Primary Completion: 2015-11-06
• Study Completion: 2015-11-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug: 0.5% ropivacaine	0.5% ropivacaine	-
Fentanyl 500mcg + acupan 160mg + nasea 0.6mg	Fentanyl 500mcg + acupan 160mg + nasea 0.6mg	-

Primary Outcome Measures

Name	Time	Method
1. Acute pain	Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)

Secondary Outcome Measures

Name	Time	Method
2. Quality of life	measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation

Trial Locations

Locations (1)

Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of