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Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Cytokine, Anesthesia, Local anesthesia, surgery, breast cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Local anesthesia
Type: Procedure
Name: General anesthesia
Type: Procedure
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 21 Years
Gender: Female
Criteria: 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
- 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
Location
Mackay memorial hospital
Taipei, Taiwan
Status: Recruiting
Contact: Yuan-Ching Chang, MD - 886-2-25433535 - yuanching.chang@gmail.com
Start Date
June 2008
Completion Date
July 2013
Sponsors
Mackay Memorial Hospital
Source
Mackay Memorial Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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