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Trial Title:
Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery
NCT ID:
NCT00938171
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Anesthetics
Conditions: Keywords:
Cytokine
Anesthesia
Local anesthesia
surgery
breast cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
Local anesthesia
Description:
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)
Arm group label:
local anesthesia
Other name:
LA
Intervention type:
Procedure
Intervention name:
General anesthesia
Description:
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.
Arm group label:
General anesthesia
Other name:
GA
Summary:
The purpose of this study is to determine therapeutic benefits by local anesthetic
technique for breast cancer.
Detailed description:
Experimental and clinical studies have shown that surgical trauma and stress affects the
immune system including both the innate and adaptive immune responses.
The break of immune homeostasis might enhance tumor growth and spread. Minimal invasive
surgical procedures have been shown to be beneficial to patients in terms of preserving
better systemic immune function. Impaired cellular immunity after general anesthesia has
significant undesirable effects on tumor surveillance after breast surgery. The local
block technique might avoid the surgery inducing neuroendocrine, metabolic, and cytokine
responses, which will offer some advantages from better preservation of early
postoperative cellular immune function and attenuate disturbance in the inflammatory
mediators. Our research will focus on the effects of local block anesthesia on mediators
that may be important in inflammatory response, tumor cell dissemination, deposition, and
propagation in the early postoperative period. As importantly, local block method is not
only a safe procedure but also reduces the need for post operative opioids and prevents
nausea following breast cancer which can result in markedly reduced hospital stay and
health costs. It is plausible that inhibition of the surgical responses by local block
anesthesia may attenuate perioperative tumor enhancing factors and/or potential
beneficial actions of lidocaine infiltration combined with propofol sedation per se in
anticancer effect to have better cancer control.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Biopsy-proven breast cancer Scheduled for mastectomy and axillary node dissection in
a single procedure.
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
21 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mackay memorial hospital
Address:
City:
Taipei
Zip:
10449
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Yuan-Ching Chang, MD
Phone:
886-2-25433535
Phone ext:
3060
Email:
yuanching.chang@gmail.com
Investigator:
Last name:
Yuan-Ching Chang, MD
Email:
Principal Investigator
Start date:
June 2008
Completion date:
July 2013
Lead sponsor:
Agency:
Mackay Memorial Hospital
Agency class:
Other
Collaborator:
Agency:
National Science Council, Taiwan
Agency class:
Other
Source:
Mackay Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00938171
