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Clinical Trials/NCT00938171
NCT00938171
Unknown
Phase 3

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

Mackay Memorial Hospital1 site in 1 country40 target enrollmentJune 2008
ConditionsBreast Cancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Mackay Memorial Hospital
Enrollment
40
Locations
1
Primary Endpoint
Visual Analog Scale (VAS) pain scores
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
July 2013
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) pain scores

Time Frame: Until PACU discharge and for 24 hours

Secondary Outcomes

  • disease free survival(5 years)
  • Episodes of nausea or vomiting(24 hours)
  • Overall patient satisfaction(After hospital discharge and six months later)
  • The need for postoperative opioids(24 hours)

Study Sites (1)

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