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Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer


N/A
18 Years
85 Years
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

Impact of Regional Anesthesia Versus General Anesthesia on Immune Modulation and Clearance of Circulating Tumor Cells (CTC) in Subjects Undergoing Surgery for Primary Nonmetastatic Breast Cancer


There are two different types of anesthesia that the investigators can use for subjects
undergoing breast surgery. The first type is called "general anesthesia" (GA) which is when
a person "goes to sleep" with a breathing tube and then receives intravenous (IV) pain
medicine during and after surgery to minimize surgical pain. The other type of anesthesia is
called "regional anesthesia" (RA), or "nerve blocks" which numb up the nerves that supply
the breast area. By doing this type of anesthesia, subjects often don't go "to sleep" with a
breathing tube, instead, they get heavy IV sedation and take a "deep nap" during the
surgery.


Inclusion Criteria:



- Male and female subjects should be over 18 years of age and capable of providing
informed consent indicating awareness of the investigational nature of this trial, in
keeping with institutional policy

- Written informed consent must be obtained from each subject prior to entering the
study

- Subjects with primary non-metastatic AJCC stages I, II or III, scheduled to undergo
either unilateral mastectomy with or without Sentinel lymph node biopsy or axillary
dissection, or unilateral lumpectomy with Sentinel lymph node biopsy or axillary
lymph node dissection

- Able to stay overnight in the hospital post surgery

Exclusion Criteria:

- Any subject younger than 18 years or older than 85 years of age

- History of previous breast surgery (aside from biopsy), planned breast conserving
operation (isolated lumpectomy) or reconstruction (rectus or latissimus flap)

- American Society of Anesthesia (ASA) classification of 4 or greater, or any
contraindication to having regional anesthesia

- Any subjects who receives an intraoperative or postoperative blood transfusion during
the period of venous blood sampling

- Subjects who are pregnant. Exclusion of the possibility of pregnancy by testing
(urine HCG) or by history (tubal ligation, hysterectomy, or menopause) is required
prior to inclusion in the study

- Subjects with active infectious process at the site of proposed paravertebral
injection

- Subjects with significant allergy to local anesthetics

- Subjects who convert from RA to GA during surgery

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Circulating Tumor Cells

Outcome Description:

blood will be drawn preoperative( at least 24 hours before surgery), immediate prior to surgery, immediately postoperative, 12-24 hours postoperative, and at postoperative appointment

Outcome Time Frame:

5 days

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

355841-17

NCT ID:

NCT01716065

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Anesthesia, Circulating tumor cells
  • Breast Neoplasms
  • Neoplastic Cells, Circulating

Name

Location

Walter Reed National Military Medical CenterBethesda, Maryland  20889