Comparison of Paravertebral Block With General Anesthesia in Patients Undergoing Breast Cancer Surgery

Condition(s) targeted: Breast Cancer

Intervention: Paravertebral Block (Procedure); General Anesthesia (Procedure)

Phase: Phase 3

Status: Recruiting

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

Overall contact:
Kathryn Koval, BA, Phone: 212-746-2952, Email: kak2006@med.cornell.edu

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

Primary outcome:

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.

Secondary outcome:

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

Detailed description: 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. Gender(s): Female.

Criteria:

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.

Kathryn Koval, BA, Phone: 212-746-2952, Email: kak2006@med.cornell.edu

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: tft9001@med.cornell.edu
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

Related publications:

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.

Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5.

Karmakar MK, Booker PD, Franks R. Bilateral continuous paravertebral block used for postoperative analgesia in an infant having bilateral thoracotomy. Paediatr Anaesth. 1997;7(6):469-71.

Richardson J, Vowden P, Sabanathan S. Bilateral paravertebral analgesia for major abdominal vascular surgery: a preliminary report. Anaesthesia. 1995 Nov;50(11):995-8.

Wassef MR, Randazzo T, Ward W. The paravertebral nerve root block for inguinal herniorrhaphy--a comparison with the field block approach. Reg Anesth Pain Med. 1998 Sep-Oct;23(5):451-6.

Eason MJ, Wyatt R. Paravertebral thoracic block-a reappraisal. Anaesthesia. 1979 Jul-Aug;34(7):638-42.

Gilbert J, Hultman J. Thoracic paravertebral block: a method of pain control. Acta Anaesthesiol Scand. 1989 Feb;33(2):142-5.

Cheema SP, Ilsley D, Richardson J, Sabanathan S. A thermographic study of paravertebral analgesia. Anaesthesia. 1995 Feb;50(2):118-21.

Terheggen MA, Wille F, Borel Rinkes IH, Ionescu TI, Knape JT. Paravertebral blockade for minor breast surgery. Anesth Analg. 2002 Feb;94(2):355-9, table of contents.

Evans PJ, Lloyd JW, Wood GJ. Accidental intrathecal injection of bupivacaine and dextran. Anaesthesia. 1981 Jul;36(7):685-7.

Lönnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5.

Chan VW, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-7.

Marhofer P, Sitzwohl C, Greher M, Kapral S. Ultrasound guidance for infraclavicular brachial plexus anaesthesia in children. Anaesthesia. 2004 Jul;59(7):642-6.

Sandhu NS, Manne JS, Medabalmi PK, Capan LM. Sonographically guided infraclavicular brachial plexus block in adults: a retrospective analysis of 1146 cases. J Ultrasound Med. 2006 Dec;25(12):1555-61.

Pusch F, Wildling E, Klimscha W, Weinstabl C. Sonographic measurement of needle insertion depth in paravertebral blocks in women. Br J Anaesth. 2000 Dec;85(6):841-3.

18. Greengrass R., O'Brien F., Lyerly K., Hardman D. Gleason D., D'Ercole F., Steele S. Paravertebral block for breast cancer surgery. Acta Anaesthesiol Scand 1999; 43: 770-74.

Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26.

Najarian MM, Johnson JM, Landercasper J, Havlik P, Lambert PJ, McCarthy D. Paravertebral block: an alternative to general anesthesia in breast cancer surgery. Am Surg. 2003 Mar;69(3):213-8; discussion 218.

21. Karmakar M.K. Thoracic Paravertebral Block. Anesthesiology 2001; 95: 771-80.

Starting date: April 2008
Last updated: April 30, 2009