Clinical trial NCT00938171: Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery
Official title: A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Cytokine
Anesthesia
Local anesthesia
surgery
breast cancer
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2009-07-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Visual Analog Scale (VAS) pain scores
timeFrame: Until PACU discharge and for 24 hours
Secondary outcomes:
measure: disease free survival
timeFrame: 5 years
measure: Episodes of nausea or vomiting
timeFrame: 24 hours
measure: Overall patient satisfaction
timeFrame: After hospital discharge and six months later
measure: The need for postoperative opioids
timeFrame: 24 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay memorial hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: YuanChing Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: