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OpenTrials
Completed

NCT Number: NCT01716065

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Circulating Tumor Cells

    Time frame: 5 days

    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

Secondary outcomes

  1. Levels of cytokines

    Time frame: 5 days

  2. breast cancer antibodies

    Time frame: 5 days

  3. Dendritic Cells

    Time frame: 5 days

  4. T and B lymphocytes

    Time frame: 5 days

  5. Natural Killer Cells (NK cells)

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Defense and Veterans Center for Integrative Pain Management

Other

Registry information

Official study title

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

Acronym: CTC

Important dates

Study start
2012
Primary completion
2013
First posted
Oct 29, 2012
Registry last updated
Apr 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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