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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT01703351

Collaborator

(none)

Enrollment

Location

Arms

37.1

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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 Neoplasms Postoperative Pain	Drug: 0.5% ropivacaine Drug: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Oct 4, 2012

Actual Primary Completion Date :

Nov 6, 2015

Actual Study Completion Date :

Nov 6, 2015

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

3. Neuropathic pain [VAS score and dose of analgesics in 4, 12 weeks after operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT01703351

Other Study ID Numbers:

4-2012-0470

First Posted:

Oct 10, 2012

Last Update Posted:

Jan 31, 2019

Last Verified:

Jan 1, 2019

Keywords provided by Yonsei University

pain control, VATS

Additional relevant MeSH terms:

Lung Neoplasms

Fentanyl

Ropivacaine

Study Results

No Results Posted as of Jan 31, 2019