Comparison of Paravertebral Block With General Anesthesia in Patients Undergoing Breast Cancer Surgery
Information source: Weill Medical College of Cornell University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Paravertebral Block (Procedure); General Anesthesia (Procedure)
Phase: Phase 3
Sponsored by: Weill Medical College of Cornell University
Official(s) and/or principal investigator(s):
Tiffany Tedore, M.D., Principal Investigator, Affiliation: New York Presbyterian Hospital Weill Cornell Medical Center
Kathryn Koval, BA, Phone: 212-746-2952, Email: firstname.lastname@example.org
The purpose of this project is to determine if there is a difference between paravertebral
block and general anesthesia in terms of time to discharge from the Post-Anesthesia Care
Unit and pain level in patients undergoing outpatient breast cancer surgery.
Official title: A Comparison of Ultrasound-Assisted Paravertebral Block and General Anesthesia for Outpatient Breast Cancer Surgery, a Prospective Randomized Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Time in minutes until the patient is declared ready for discharge from the Post Anesthesia Care Unit (PACU)
Visual Analog Scale (VAS) pain scores at 30, 60, 90, and 120 minutes after PACU admission. A VAS score will also be assessed on the first postoperative day.
The need for postoperative opioids in the PACU and during the first postoperative day will be assessed.
Episodes of nausea or vomiting in the PACU and during the first postoperative day will be assessed.
Total time spent in the operating room
Overall patient satisfaction
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.
Minimum age: 18 Years.
Maximum age: N/A.
- Women 18 years of age or older with suspected breast carcinoma scheduled for
unilateral lumpectomy or mass excision with sentinel node biopsy and possible
- 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.
Locations and Contacts
Kathryn Koval, BA, Phone: 212-746-2952, Email: email@example.com
New York Presbyterian Hospital Weill Cornell Medical Center, New York, New York 10065, United States; Recruiting
Tiffany Tedore, M.D., Phone: 212-746-2725, Email: firstname.lastname@example.org
Tiffany Tiffany Tedore, M.D., Principal Investigator
Eugene Nowak, M.D., Sub-Investigator
Eleni Tousimis, M.D., Sub-Investigator
Christopher Choi, M.D., Sub-Investigator
Matthew Bertram, M.D., Sub-Investigator
David Kopman, M.D., Sub-Investigator
Maryam Ghods, M.D., Sub-Investigator
Peleg Perelmuter, M.D., Sub-Investigator
Alexander Wolfson, M.D., Sub-Investigator
Shannon Men, B.A, Sub-Investigator
Daniel Feiler, B.S, Sub-Investigator
Jacqueline Bogan, B.A, Sub-Investigator
Pusch F, Freitag H, Weinstabl C, Obwegeser R, Huber E, Wildling E. Single-injection paravertebral block compared to general anaesthesia in breast surgery. Acta Anaesthesiol Scand. 1999 Aug;43(7):770-4.
McCartney CJ, Brull R, Chan VW, Katz J, Abbas S, Graham B, Nova H, Rawson R, Anastakis DJ, von Schroeder H. Early but no long-term benefit of regional compared with general anesthesia for ambulatory hand surgery. Anesthesiology. 2004 Aug;101(2):461-7. Erratum in: Anesthesiology. 2004 Oct;101(4):1057.
Coveney E, Weltz CR, Greengrass R, Iglehart JD, Leight GS, Steele SM, Lyerly HK. Use of paravertebral block anesthesia in the surgical management of breast cancer: experience in 156 cases. Ann Surg. 1998 Apr;227(4):496-501.
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Chan VW, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-7.
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Starting date: April 2008
Last updated: April 30, 2009