Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery
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Purpose
The purpose of this study is to determine therapeutic benefits by local anesthetic technique for breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Procedure: Local anesthesia Procedure: General anesthesia |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial |
- Visual Analog Scale (VAS) pain scores [ Time Frame: Until PACU discharge and for 24 hours ] [ Designated as safety issue: No ]
- disease free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Episodes of nausea or vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Overall patient satisfaction [ Time Frame: After hospital discharge and six months later ] [ Designated as safety issue: No ]
- The need for postoperative opioids [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: local anesthesia
local anesthesia with propofol sedation Target-controlled infusion (TCI) system will be used to maintain proper sedation level)
|
Procedure: Local anesthesia
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)
Other Name: LA
|
|
Active Comparator: General anesthesia
Patients receiving general anesthesia
|
Procedure: General anesthesia
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.
Other Name: GA
|
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.
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Yuan-Ching Chang, MD | 886-2-25433535 | yuanching.chang@gmail.com |
| Contact: Yuan-Ching Chang, MD |
| Taiwan | |
| Mackay memorial hospital | Recruiting |
| Taipei, Taiwan, 10449 | |
| Contact: Yuan-Ching Chang, MD 886-2-25433535 ext 3060 yuanching.chang@gmail.com | |
| Principal Investigator: Yuan-Ching Chang, MD | |
| Principal Investigator: | YuanChing Chang, MD | Mackay Memorial Hospital |
More Information
No publications provided
| Responsible Party: | Yuan-Ching Chang MD, Mackay Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00938171 History of Changes |
| Other Study ID Numbers: | MMH-I-S538, 97WHK0900049 |
| Study First Received: | July 10, 2009 |
| Last Updated: | July 10, 2009 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Mackay Memorial Hospital:
|
Cytokine Anesthesia Local anesthesia surgery breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013