Pain Control of Thoracoscopic Major Pulmonary Resection
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pre-emptive bupivacaine wound infiltration
intravenous patient controlled analgesia
Sponsored by

About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Video Assisted Thoracic Surgery, Postoperative Pain, Intravenous Patient Controlled Analgesia, Bupivacaine, Major Pulmonary Resection, Post Pulmonary Resection
Eligibility Criteria
Inclusion Criteria:
- patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity
Exclusion Criteria:
- not done by VATS anatomical resection
- patient does not agree to the study
- postoperative hospital stay exceeds 7 days due to postoperative complications
- existence of preoperative renal insufficiency (Cr > 1.5)
- OT/PT > 120
- history of Lidocaine hypersensitivity
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Bupivacaine
Intravenous Patient Controlled Analgesia
Arm Description
postoperative pain control with intravenous patient controlled analgesia
Outcomes
Primary Outcome Measures
The change in postoperative pain confirmed by Visual Analogue Pain Scale
Secondary Outcome Measures
number of participants with adverse events related to fentanyl or bupivacaine drug
nausea, vomiting, sleepiness, urinary difficulty, respiratory depression
Full Information
NCT ID
NCT01758809
First Posted
September 28, 2011
Last Updated
December 25, 2012
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01758809
Brief Title
Pain Control of Thoracoscopic Major Pulmonary Resection
Official Title
Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.
Detailed Description
Despite less postoperative pain from Video Assisted Thoracic Surgery (VATS) than thoracotomy, pain is still an important issue in its recovery period. After VATS procedure, intravenous patient controlled analgesia (IV PCA) is being used for pain control. However, the side effects of IV PCA are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. It is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Video Assisted Thoracic Surgery, Postoperative Pain, Intravenous Patient Controlled Analgesia, Bupivacaine, Major Pulmonary Resection, Post Pulmonary Resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Title
Intravenous Patient Controlled Analgesia
Arm Type
Other
Arm Description
postoperative pain control with intravenous patient controlled analgesia
Intervention Type
Procedure
Intervention Name(s)
Pre-emptive bupivacaine wound infiltration
Intervention Description
Pre-emptive bupivacaine wound infiltration
Intervention Type
Procedure
Intervention Name(s)
intravenous patient controlled analgesia
Intervention Description
postoperative pain control with intravenous patient controlled analgesia
Primary Outcome Measure Information:
Title
The change in postoperative pain confirmed by Visual Analogue Pain Scale
Time Frame
Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months
Secondary Outcome Measure Information:
Title
number of participants with adverse events related to fentanyl or bupivacaine drug
Description
nausea, vomiting, sleepiness, urinary difficulty, respiratory depression
Time Frame
2 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity
Exclusion Criteria:
not done by VATS anatomical resection
patient does not agree to the study
postoperative hospital stay exceeds 7 days due to postoperative complications
existence of preoperative renal insufficiency (Cr > 1.5)
OT/PT > 120
history of Lidocaine hypersensitivity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanghoon Jheon, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hee Chul Yang, M.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pain Control of Thoracoscopic Major Pulmonary Resection
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