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A Comparison of Ultrasound-assisted Paravertebral Block and General Anesthesia for Outpatient Breast Cancer Surgery, a Prospective Randomized Trial

Phase 3
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Comparison of Ultrasound-assisted Paravertebral Block and General Anesthesia for Outpatient Breast Cancer Surgery, a Prospective Randomized Trial

The optimal anesthetic technique for breast cancer surgery allows for good postoperative
pain relief and rapid discharge. Breast cancer surgery with potential axillary dissection is
often performed under general anesthesia due to the potential for poor analgesia with local
anesthetic infiltration at the surgical site alone. General anesthesia can be associated
with increased post-operative pain, nausea, and delayed discharge when compared to regional
anesthesia for breast and other types of procedures (1,2).

The paravertebral block is a technique that has been used perioperatively for breast (3,4),
thoracic (5), abdominal (6), and hernia surgeries (7). It has also been used for pain
control after rib fractures and penetrating trauma (8,9). The paravertebral block is
performed by injecting local anesthetic above or below the transverse processes of the
vertebral bodies where the spinal nerve roots emerge from the intervertebral foramina. The
most common technique is to insert a needle 2.5 centimeters lateral to the spinous process
at each level and "walk off" the transverse process. Injections at one or multiple levels
block the somatic and sympathetic innervation to these dermatomes (10).

Rare complications of thoracic paravertebral blocks include epidural spread, intrathecal
injection, and Horner's Syndrome (1,11,12). One of the most feared complications of the
traditional technique is pleural puncture, which has an incidence of 0.64% to 6.7% in the
published literature (3,11,13).

Ultrasound guidance in regional anesthesia is gaining widespread popularity. This
technology provides visualization of key anatomic structures and has been shown to decrease
block placement and onset times (14,15) and improve patient comfort (15). Ultrasound-guided
blocks are associated with success rates of greater than 90% (15,16). In the thoracic
region, ultrasound can be used to identify the vertebral transverse processes, as well as
the ribs and the pleura of the lungs (17). In this way, pleural puncture can be avoided
during paravertebral block placement.

To date there have been no published prospective, randomized trials comparing the multiple
injection thoracic paravertebral technique using ultrasound guidance to general anesthesia
in breast cancer surgery patients.

Our hypothesis is that paravertebral block anesthesia will result in shorter Post Anesthesia
Care Unit (PACU) stays and decreased Visual Analog Scale (VAS) scores when compared to
general anesthesia in patients undergoing breast cancer surgery. Secondary endpoints will
include the need for postoperative opioids and the presence of nausea and/or vomiting.

Inclusion Criteria:

- Women 18 years of age or older with suspected breast carcinoma scheduled for
unilateral lumpectomy or mass excision with sentinel node biopsy and possible
axillary dissection.

Exclusion Criteria:

- A diagnosis of chronic pain, regular use of opioid medications, infection at the
injection site, allergy to amide local anesthetics, bleeding disorder,
contraindication to LMA, and patient refusal.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time in minutes until the patient is declared ready for discharge from the Post Anesthesia Care Unit (PACU)

Outcome Time Frame:

Until PACU discharge

Safety Issue:


Principal Investigator

Tiffany Tedore, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Presbyterian Hospital Weill Cornell Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

March 2010

Related Keywords:

  • Breast Cancer
  • breast carcinoma
  • breast cancer
  • paravertebral block
  • comparison of paravertebral block and general anesthesia
  • ultrasound
  • Breast Neoplasms



New York Presbyterian Hospital Weill Cornell Medical Center New York City, New York  10021