Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

Phase 3

• Conditions: Breast Cancer
• Interventions: Procedure: Local anesthesia; Procedure: General anesthesia

• Registration Number: NCT00938171
• Lead Sponsor: Mackay Memorial Hospital

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.

Study Timeline

• Study Start: 2008-06
• Status Verified: 2009-07
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Last Update Submitted: 2009-07-10
• Study First Posted: 2009-07-13
• Last Update Posted: 2009-07-13
• Primary Completion: 2011-07
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local anesthesia	Local anesthesia	local anesthesia with propofol sedation Target-controlled infusion (TCI) system will be used to maintain proper sedation level)
General anesthesia	General anesthesia	Patients receiving general anesthesia

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) pain scores	Until PACU discharge and for 24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Mackay memorial hospital; 🇨🇳 Taipei, Taiwan