Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery
A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial
2 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of this study is to determine therapeutic benefits by local anesthetic technique for breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 10, 2009
CompletedFirst Posted
Study publicly available on registry
July 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 13, 2009
July 1, 2009
3.1 years
July 10, 2009
July 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale (VAS) pain scores
Until PACU discharge and for 24 hours
Secondary Outcomes (4)
disease free survival
5 years
Episodes of nausea or vomiting
24 hours
Overall patient satisfaction
After hospital discharge and six months later
The need for postoperative opioids
24 hours
Study Arms (2)
local anesthesia
ACTIVE COMPARATORlocal anesthesia with propofol sedation Target-controlled infusion (TCI) system will be used to maintain proper sedation level)
General anesthesia
ACTIVE COMPARATORPatients receiving general anesthesia
Interventions
All patients will be then given adequate sedation with propofol and local anesthetic given by dermal infiltration in incision site and regional breast and axillary areas. The local anesthetic of choice will be 2 % lidocaine (Xylocaine) and 0.5% Bupivacaine (Marcaine) mixed with 7 % sodium bicarbonate and epinephrine (Bosmine)
The method of general anesthesia for the GA group will be induced with fentanyl (1-2 μg/kg) and propofol (2.5 mg/kg). After placement of a laryngeal mask or endotracheal tube airway, anesthesia will be maintained with sevoflurane (end-tidal concentrations 1%-3%) in a 50% oxygen/nitrous oxide mixture.
Eligibility Criteria
You may qualify if:
- Biopsy-proven breast cancer Scheduled for mastectomy and axillary node dissection in a single procedure.
You may not qualify if:
- previous surgery within the preceding 2 wk those other than ASA physical status I or II any contraindication to either local anesthesia or opioid analgesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mackay memorial hospital
Taipei, 10449, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YuanChing Chang, MD
Mackay Memorial Hospital
Central Study Contacts
Yuan-Ching Chang, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 10, 2009
First Posted
July 13, 2009
Study Start
June 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2013
Last Updated
July 13, 2009
Record last verified: 2009-07