Completed

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

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What is being tested

0.5% ropivacaine

+ Fentanyl 500mcg + acupan 160mg + nasea 0.6mg

Drug
Who is being recruted

Lung Diseases+15

+ Neoplasms

+ Neoplasms by Site

From 18 to 78 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorYonsei University
Last updated: January 31, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: October 4, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorYonsei University
Last updated: January 31, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

79 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 78 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesNeoplasmsNeoplasms by SiteNervous System DiseasesNeurologic ManifestationsPainPathologic ProcessesPerceptual DisordersPostoperative ComplicationsRespiratory Tract DiseasesRespiratory Tract NeoplasmsSigns and SymptomsPathological Conditions, Signs and SymptomsThoracic NeoplasmsNeurobehavioral ManifestationsAgnosiaLung NeoplasmsPain, Postoperative

Criteria

5 inclusion criteria required to participate
Age; 18 >= , < 75

Agree with study

Karnofsky performance status >= 80

Thoracoscopic lobectomy due to lung cancer or suspected lung cancer

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11 exclusion criteria prevent from participating
Bleeding risk due to Aspirin, coumadin and other drugs

Chemical pleurodesis more than two times after operation

Do not agree with study

History of rib fracture, trauma or lung surgery at the same side of operation

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Seoul, South KoreaOpen Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine in Google Maps
CompletedOne Study Center