Pain Control of Thoracoscopic Major Pulmonary Resection
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
January 1, 2013
CompletedJanuary 1, 2013
December 1, 2012
9 months
September 28, 2011
December 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in postoperative pain confirmed by Visual Analogue Pain Scale
Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months
Secondary Outcomes (1)
number of participants with adverse events related to fentanyl or bupivacaine drug
2 months
Study Arms (2)
Bupivacaine
ACTIVE COMPARATORIntravenous Patient Controlled Analgesia
OTHERpostoperative pain control with intravenous patient controlled analgesia
Interventions
Pre-emptive bupivacaine wound infiltration
postoperative pain control with intravenous patient controlled analgesia
Eligibility Criteria
You may qualify if:
- patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sanghoon Jheon, M.D., Ph.D.
Seoul National University Bundang Hospital
- PRINCIPAL INVESTIGATOR
Hee Chul Yang, M.D.
Seoul National University Bundang Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Department of Thoracic and Cardiovascular Surgery
Study Record Dates
First Submitted
September 28, 2011
First Posted
January 1, 2013
Study Start
December 1, 2010
Primary Completion
September 1, 2011
Study Completion
November 1, 2011
Last Updated
January 1, 2013
Record last verified: 2012-12