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

This study has been completed.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00645138
First received: March 19, 2008
Last updated: August 4, 2011
Last verified: August 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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: 40
Study Start Date: April 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paravertebral Block
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.
Active Comparator: General Anesthesia
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00645138

Locations
United States, New York
New York Presbyterian Hospital Weill Cornell Medical Center
New York, New York, United States, 10065
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:
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.
21. Karmakar M.K. Thoracic Paravertebral Block. Anesthesiology 2001; 95: 771-80.

Responsible Party: Tiffany Tedore MD, New York Presbyterian Hospital Weill Cornell Medical Center
ClinicalTrials.gov Identifier: NCT00645138     History of Changes
Other Study ID Numbers: 0801009584
Study First Received: March 19, 2008
Last Updated: August 4, 2011
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

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

ClinicalTrials.gov processed this record on September 18, 2014