Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

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

Detailed Description
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Local anesthesia
* Procedure: General anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytokine, Anesthesia, Local anesthesia, surgery, breast cancer