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

The purpose of this study is to determine therapeutic benefits by local anesthetic technique for breast cancer.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Local anesthesia; Procedure: General anesthesia

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10449
    • Recruiting
    • Mackay Memorial Hospital
    • Contact: Yuan-Ching Chang, MD; Phone Number: 3060 886-2-25433535; Email: yuanching.chang@gmail.com
    • Principal Investigator: Yuan-Ching Chang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: local anesthesia; local anesthesia with propofol sedation Target-controlled infusion (TCI) system will be used to maintain proper sedation level)	Procedure: 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); Other Names: LA
Active Comparator: General anesthesia; Patients receiving general anesthesia	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.; Other Names: GA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale (VAS) pain scores	Until PACU discharge and for 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Collaborators: National Science Council, Taiwan
• Investigators: Principal Investigator: YuanChing Chang, MD, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Estimate): July 13, 2009
• Last Update Submitted That Met QC Criteria: July 10, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: breast cancer; surgery; Anesthesia; Cytokine; Local anesthesia
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: MMH-I-S538; 97WHK0900049

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No