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Sponsored by: |
Weill Medical College of Cornell University |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00645138 |
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 |
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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 |
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 |
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Paravertebral Block: Active Comparator
Patients receiving Paravertebral Block.
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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.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathryn Koval, BA | 212-746-2952 | kak2006@med.cornell.edu |
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 |
Principal Investigator: | Tiffany Tedore, M.D. | New York Presbyterian Hospital Weill Cornell Medical Center |
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 |
breast carcinoma breast cancer paravertebral block comparison of paravertebral block and general anesthesia ultrasound |
Fentanyl Skin Diseases Central Nervous System Depressants Breast Neoplasms Anesthetics Povidone-Iodine Midazolam Carcinoma |
Sevoflurane Mepivacaine Bupivacaine Ondansetron Epinephrine Propofol Breast Diseases |
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 |