Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

NCT ID: NCT00938171

Last Updated: 2009-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2013-07-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

local anesthesia

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

Group Type: ACTIVE_COMPARATOR

Local anesthesia

Intervention Type: PROCEDURE

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)

General anesthesia

Patients receiving general anesthesia

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: PROCEDURE

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.

Interventions

Local anesthesia

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

General anesthesia

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.

Intervention Type: PROCEDURE

Other Intervention Names

LA; GA

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

Mackay Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mackay Memorial Hospital

Principal Investigators

YuanChing Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Mackay Memorial Hospital

Locations

Mackay memorial hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yuan-Ching Chang, MD

Role: CONTACT

yuanching.chang@gmail.com

886-2-25433535

Yuan-Ching Chang, MD

Role: CONTACT

Facility Contacts

Yuan-Ching Chang, MD

Role: primary

yuanching.chang@gmail.com

886-2-25433535 ext. 3060

Other Identifiers

97WHK0900049

Identifier Type: -

Identifier Source: secondary_id

MMH-I-S538

Identifier Type: -

Identifier Source: org_study_id