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

January 29, 2019 updated by: Yonsei University
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 120-752
        • Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
(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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
measured Quality of life by EORTC QLQ C 30 (V 3.0) in 4, 8, 12 weeks after operation

Other Outcome Measures

Outcome Measure
Time Frame
3. Neuropathic pain
Time Frame: VAS score and dose of analgesics in 4, 12 weeks after operation
VAS score and dose of analgesics in 4, 12 weeks after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 4, 2012

Primary Completion (Actual)

November 6, 2015

Study Completion (Actual)

November 6, 2015

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 7, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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