search
Back to results

Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Local anesthesia
General anesthesia
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Cytokine, Anesthesia, Local anesthesia, surgery, breast cancer

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay memorial hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

local anesthesia

General anesthesia

Arm Description

local anesthesia with propofol sedation Target-controlled infusion (TCI) system will be used to maintain proper sedation level)

Patients receiving general anesthesia

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) pain scores

Secondary Outcome Measures

disease free survival
Episodes of nausea or vomiting
Overall patient satisfaction
The need for postoperative opioids

Full Information

First Posted
July 10, 2009
Last Updated
July 10, 2009
Sponsor
Mackay Memorial Hospital
Collaborators
National Science Council, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT00938171
Brief Title
Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery
Official Title
A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mackay Memorial Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cytokine, Anesthesia, Local anesthesia, surgery, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
local anesthesia
Arm Type
Active Comparator
Arm Description
local anesthesia with propofol sedation Target-controlled infusion (TCI) system will be used to maintain proper sedation level)
Arm Title
General anesthesia
Arm Type
Active Comparator
Arm Description
Patients receiving general anesthesia
Intervention Type
Procedure
Intervention Name(s)
Local anesthesia
Other Intervention Name(s)
LA
Intervention 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)
Intervention Type
Procedure
Intervention Name(s)
General anesthesia
Other Intervention Name(s)
GA
Intervention 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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) pain scores
Time Frame
Until PACU discharge and for 24 hours
Secondary Outcome Measure Information:
Title
disease free survival
Time Frame
5 years
Title
Episodes of nausea or vomiting
Time Frame
24 hours
Title
Overall patient satisfaction
Time Frame
After hospital discharge and six months later
Title
The need for postoperative opioids
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan-Ching Chang, MD
Phone
886-2-25433535
Email
yuanching.chang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan-Ching Chang, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YuanChing Chang, MD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay memorial hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan-Ching Chang, MD
Phone
886-2-25433535
Ext
3060
Email
yuanching.chang@gmail.com
First Name & Middle Initial & Last Name & Degree
Yuan-Ching Chang, MD

12. IPD Sharing Statement

Learn more about this trial

Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

We'll reach out to this number within 24 hrs