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Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

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ClinicalTrials.gov Identifier: NCT00938171
Recruitment Status : Unknown
Verified July 2009 by Mackay Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : July 13, 2009
Last Update Posted : July 13, 2009
Sponsor:
Collaborator:
Information provided by:

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

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Local anesthesia Procedure: General anesthesia Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial
Study Start Date : June 2008
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Visual Analog Scale (VAS) pain scores [ Time Frame: Until PACU discharge and for 24 hours ]

Secondary Outcome Measures :
  1. disease free survival [ Time Frame: 5 years ]
  2. Episodes of nausea or vomiting [ Time Frame: 24 hours ]
  3. Overall patient satisfaction [ Time Frame: After hospital discharge and six months later ]
  4. The need for postoperative opioids [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938171


Contacts
Contact: Yuan-Ching Chang, MD 886-2-25433535 yuanching.chang@gmail.com
Contact: Yuan-Ching Chang, MD

Locations
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         
Sponsors and Collaborators
Mackay Memorial Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: YuanChing Chang, MD Mackay Memorial Hospital
More Information

Responsible Party: Yuan-Ching Chang MD, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT00938171     History of Changes
Other Study ID Numbers: MMH-I-S538
97WHK0900049
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: July 13, 2009
Last Verified: July 2009

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
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General