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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

Primary Purpose

Lung Neoplasms, Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
0.5% ropivacaine
Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring pain control, VATS

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug: 0.5% ropivacaine

Fentanyl 500mcg + acupan 160mg + nasea 0.6mg

Arm Description

Outcomes

Primary Outcome Measures

1. Acute pain

Secondary Outcome Measures

2. Quality of life

Full Information

First Posted
September 27, 2012
Last Updated
January 29, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01703351
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2012 (undefined)
Primary Completion Date
November 6, 2015 (Actual)
Study Completion Date
November 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Postoperative Pain
Keywords
pain control, VATS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: 0.5% ropivacaine
Arm Type
Experimental
Arm Title
Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
0.5% ropivacaine
Intervention Description
(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)
Intervention Type
Drug
Intervention Name(s)
Fentanyl 500mcg + acupan 160mg + nasea 0.6mg
Intervention Description
(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)
Primary Outcome Measure Information:
Title
1. Acute pain
Time Frame
Pain score(Visual Analogue Scale) measured in operative day, POD #1, #2, #3, #4)
Secondary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
3. Neuropathic pain
Time Frame
VAS score and dose of analgesics in 4, 12 weeks after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Thoracic and Cardiovascular Surgery, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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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