Prospective Randomized Trial Comparing the Effectiveness... | NCT01703351

Studies
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

NCT01703351

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Jan 31, 2019Actual

Enrollment

79Actual

Phase

Phase 2

Conditions

Lung Neoplasms
Postoperative Pain

Interventions

0.5% ropivacaine
Fentanyl 500mcg + acupan 160mg + nasea 0.6mg

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 4, 2012

Primary Completion Date

Nov 6, 2015Actual

Completion Date

Nov 6, 2015Actual

First Submitted Date

Sep 27, 2012

First Submission Date that Met QC Criteria

Oct 7, 2012

First Posted Date

Oct 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2019

Last Update Posted Date

Jan 31, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug: 0.5% ropivacaine	Experimental		Drug: 0.5% ropivacaine
Fentanyl 500mcg + acupan 160mg + nasea 0.6mg	Active Comparator		Drug: Fentanyl 500mcg + acupan 160mg + nasea 0.6mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.5% ropivacaine	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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

78 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine		Seoul		120-752	South Korea

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D010149	Pain, Postoperative
D000377	Agnosia

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009422	Nervous System Diseases

ID	Term
D000077212	Ropivacaine
D005283	Fentanyl
D009340	Nefopam
C071315	ramosetron

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D010079	Oxazocines
D001392	Azocines