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

NCT00645138 | Completed Phase 3

• 1 other identifier: 0801009584
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast carcinoma; breast cancer; paravertebral block; comparison of paravertebral block and general anesthesia; ultrasound

Outcome Measures

Primary Outcomes (2)

• Time in minutes until the patient is declared ready for discharge from the Post Anesthesia Care Unit (PACU)

  Until PACU discharge

• 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.

  Until PACU discharge and for 24 hours

Secondary Outcomes (4)

• The need for postoperative opioids in the PACU and during the first postoperative day will be assessed.

  24 hours

• Episodes of nausea or vomiting in the PACU and during the first postoperative day will be assessed.

  24 hours

• Total time spent in the operating room

  Perioperative

• Overall patient satisfaction

  After hospital discharge

Study Arms (2)

Paravertebral Block

ACTIVE COMPARATOR

Patients receiving Paravertebral Block.

Procedure: Paravertebral Block

General Anesthesia

ACTIVE COMPARATOR

Patients receiving General Anesthesia.

Procedure: General Anesthesia

Interventions

Paravertebral Block PROCEDURE

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.

Paravertebral Block

General Anesthesia PROCEDURE

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.

General Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Presbyterian Hospital Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Related Publications (22)

• 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. doi: 10.1034/j.1399-6576.1999.430714.x.

  PMID: 10456819 BACKGROUND

• 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. doi: 10.1097/00000542-200408000-00028.

  PMID: 15277930 BACKGROUND

• 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. doi: 10.1097/00000658-199804000-00008.

  PMID: 9563536 BACKGROUND

• Klein SM, Bergh A, Steele SM, Georgiade GS, Greengrass RA. Thoracic paravertebral block for breast surgery. Anesth Analg. 2000 Jun;90(6):1402-5. doi: 10.1097/00000539-200006000-00026.

  PMID: 10825328 BACKGROUND

• 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. doi: 10.1046/j.1460-9592.1997.d01-118.x.

  PMID: 9365974 BACKGROUND

• Richardson J, Vowden P, Sabanathan S. Bilateral paravertebral analgesia for major abdominal vascular surgery: a preliminary report. Anaesthesia. 1995 Nov;50(11):995-8. doi: 10.1111/j.1365-2044.1995.tb05939.x.

  PMID: 8678263 BACKGROUND

• 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. doi: 10.1016/s1098-7339(98)90026-8.

  PMID: 9773696 BACKGROUND

• Eason MJ, Wyatt R. Paravertebral thoracic block-a reappraisal. Anaesthesia. 1979 Jul-Aug;34(7):638-42. doi: 10.1111/j.1365-2044.1979.tb06363.x.

  PMID: 517716 BACKGROUND

• Gilbert J, Hultman J. Thoracic paravertebral block: a method of pain control. Acta Anaesthesiol Scand. 1989 Feb;33(2):142-5. doi: 10.1111/j.1399-6576.1989.tb02877.x.

  PMID: 2922982 BACKGROUND

• Cheema SP, Ilsley D, Richardson J, Sabanathan S. A thermographic study of paravertebral analgesia. Anaesthesia. 1995 Feb;50(2):118-21. doi: 10.1111/j.1365-2044.1995.tb15092.x.

  PMID: 7710020 BACKGROUND

• 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. doi: 10.1097/00000539-200202000-00023.

  PMID: 11812698 BACKGROUND

• Evans PJ, Lloyd JW, Wood GJ. Accidental intrathecal injection of bupivacaine and dextran. Anaesthesia. 1981 Jul;36(7):685-7. doi: 10.1111/j.1365-2044.1981.tb08781.x.

  PMID: 6168207 BACKGROUND

• Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x.

  PMID: 7573876 BACKGROUND

• Chan VWS, Perlas A, Rawson R, Odukoya O. Ultrasound-guided supraclavicular brachial plexus block. Anesth Analg. 2003 Nov;97(5):1514-1517. doi: 10.1213/01.ANE.0000062519.61520.14.

  PMID: 14570677 BACKGROUND

• Marhofer P, Sitzwohl C, Greher M, Kapral S. Ultrasound guidance for infraclavicular brachial plexus anaesthesia in children. Anaesthesia. 2004 Jul;59(7):642-6. doi: 10.1111/j.1365-2044.2004.03669.x.

  PMID: 15200537 BACKGROUND

• 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. doi: 10.7863/jum.2006.25.12.1555.

  PMID: 17121950 BACKGROUND

• 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. doi: 10.1093/bja/85.6.841.

  PMID: 11732516 BACKGROUND

• Greengrass R, O'Brien F, Lyerly K, Hardman D, Gleason D, D'Ercole F, Steele S. Paravertebral block for breast cancer surgery. Can J Anaesth. 1996 Aug;43(8):858-61. doi: 10.1007/BF03013039.

  PMID: 8840066 BACKGROUND

• Weltz CR, Greengrass RA, Lyerly HK. Ambulatory surgical management of breast carcinoma using paravertebral block. Ann Surg. 1995 Jul;222(1):19-26. doi: 10.1097/00000658-199507000-00004.

  PMID: 7618963 BACKGROUND

• 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.

  PMID: 12678477 BACKGROUND

• Karmakar MK. Thoracic paravertebral block. Anesthesiology. 2001 Sep;95(3):771-80. doi: 10.1097/00000542-200109000-00033. No abstract available.

  PMID: 11575553 BACKGROUND

• Chhabra A, Roy Chowdhury A, Prabhakar H, Subramaniam R, Arora MK, Srivastava A, Kalaivani M. Paravertebral anaesthesia with or without sedation versus general anaesthesia for women undergoing breast cancer surgery. Cochrane Database Syst Rev. 2021 Feb 25;2(2):CD012968. doi: 10.1002/14651858.CD012968.pub2.

  PMID: 33629404 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Tiffany Tedore, M.D.

  New York Presbyterian Hospital Weill Cornell Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 27, 2008
• Study Start: April 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 5, 2011

Record last verified: 2011-08

Locations

US (1)