Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

Mackay Memorial Hospital

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Procedure: General anesthesia; Procedure: Local anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT00938171

MMH-I-S538

97WHK0900049

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 21 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

local anesthesia

Active Comparator group

Description:

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

Treatment:

Procedure: Local anesthesia

General anesthesia

Active Comparator group

Description:

Patients receiving general anesthesia

Treatment:

Procedure: General anesthesia