Regional Anesthesia Versus General Anesthesia on Circulating Tumor Cells (CTC)

Completed

Conditions studied: Breast Cancer

In brief

The purpose of the study is to determine whether the type of anesthesia during breast cancer surgery has any impact on the way a patient's immune system functions for a brief period after surgery. If the investigators find that one type of anesthesia versus the other is more beneficial to a patient's immune system, then the investigators may use this information to design a larger study to exam the effect of anesthesia better.

Key facts

Study ID

NCT01716065

Run by

Defense and Veterans Center for Integrative Pain Management

People needed

12

Starts

2012-06-01

Last updated by the study team

2014-04-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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