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Comparison of Paravertebral Block With General Anesthesia in Patients Undergoing Breast Cancer Surgery
This study is currently recruiting participants.
Verified by Weill Medical College of Cornell University, April 2009
First Received: March 19, 2008   Last Updated: April 30, 2009   History of Changes
Sponsored by: Weill Medical College of Cornell University
Information provided by: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00645138
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: Paravertebral Block
Procedure: General Anesthesia
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title: A Comparison of Ultrasound-Assisted Paravertebral Block and General Anesthesia for Outpatient Breast Cancer Surgery, a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Time in minutes until the patient is declared ready for discharge from the Post Anesthesia Care Unit (PACU) [ Time Frame: Until PACU discharge ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Until PACU discharge and for 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The need for postoperative opioids in the PACU and during the first postoperative day will be assessed. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Episodes of nausea or vomiting in the PACU and during the first postoperative day will be assessed. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Total time spent in the operating room [ Time Frame: Perioperative ] [ Designated as safety issue: No ]
  • Overall patient satisfaction [ Time Frame: After hospital discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: April 2008
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Paravertebral Block: Active Comparator
Patients receiving Paravertebral Block.
Procedure: Paravertebral Block

Sedation will be provided with midazolam and fentanyl. The transverse processes of T1-T6 will be located using ultrasound guidance. The area will be prepped with betadine. At each level, a 21 Gauge, 4-inch Stimuplex needle will be inserted in order to make contact with the transverse process. Once the transverse process has been located, the needle will be "walked off" the process and inserted 1 cm deep to its inferior border.

After negative aspiration, 3 mL of 1.5% mepivacaine with epinephrine 1:200,000 and bicarbonate and 3 mL of 0.5% bupivacaine with epinephrine 1:200,000 will be injected. Sedation will be provided with 50-100 mcg/kg/min of propofol during the surgical procedure. Approximately 20 minutes before the end of the procedure, 4 mg of zofran will be administered.

General Anesthesia: Active Comparator
Patients receiving General Anesthesia.
Procedure: General Anesthesia
Patients in the general anesthesia group will receive midazolam preoperatively for anxiolysis. Anesthesia will be induced with propofol and fentanyl. An LMA will be inserted and anesthesia maintained with sevoflurane in air and oxygen. 4 mg of zofran will be administered approximately 20 minutes before the end of the surgical procedure. The LMA will be removed and the patient will be transported to the PACU at the conclusion of the surgery.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645138

Contacts
Contact: Kathryn Koval, BA 212-746-2952 kak2006@med.cornell.edu

Locations
United States, New York
New York Presbyterian Hospital Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Tiffany Tedore, M.D.     212-746-2725     tft9001@med.cornell.edu    
Principal Investigator: Tiffany Tiffany Tedore, M.D.            
Sub-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            
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Tiffany Tedore, M.D. New York Presbyterian Hospital Weill Cornell Medical Center
  More Information

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.

Responsible Party: New York Presbyterian Hospital Weill Cornell Medical Center ( Tiffany Tedore MD )
Study ID Numbers: 0801009584
Study First Received: March 19, 2008
Last Updated: April 30, 2009
ClinicalTrials.gov Identifier: NCT00645138     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
breast carcinoma
breast cancer
paravertebral block
comparison of paravertebral block and general anesthesia
ultrasound

Study placed in the following topic categories:
Fentanyl
Skin Diseases
Central Nervous System Depressants
Breast Neoplasms
Anesthetics
Povidone-Iodine
Midazolam
Carcinoma
Sevoflurane
Mepivacaine
Bupivacaine
Ondansetron
Epinephrine
Propofol
Breast Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Skin Diseases
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Breast Neoplasms
Central Nervous System Agents
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009