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A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial

Phase 3
21 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Visual Analog Scale (VAS) pain scores

Outcome Time Frame:

Until PACU discharge and for 24 hours

Safety Issue:


Principal Investigator

YuanChing Chang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mackay Memorial Hospital


Taiwan: Institutional Review Board

Study ID:




Start Date:

June 2008

Completion Date:

July 2013

Related Keywords:

  • Breast Cancer
  • Cytokine
  • Anesthesia
  • Local anesthesia
  • surgery
  • breast cancer
  • Breast Neoplasms