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Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00938171
Enrollment
40
Registered
2009-07-13
Start date
2008-06-30
Completion date
2013-07-31
Last updated
2009-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Cytokine, Anesthesia, Local anesthesia, surgery, breast cancer

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.

Interventions

PROCEDURELocal 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)

PROCEDUREGeneral 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.

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Visual Analog Scale (VAS) pain scoresUntil PACU discharge and for 24 hours

Secondary

MeasureTime frame
disease free survival5 years
Episodes of nausea or vomiting24 hours
Overall patient satisfactionAfter hospital discharge and six months later
The need for postoperative opioids24 hours

Countries

Taiwan

Contacts

Backup ContactYuan-Ching Chang, MD
Primary ContactYuan-Ching Chang, MD
yuanching.chang@gmail.com886-2-25433535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026