Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery

Breast Neoplasms Clinical Trial

Official title:

A Comparison Of Ultrasound and Predetermined Distance Techniques For Paravertebral Space Localization In Breast Surgery: A Randomized Prospective Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01217593
• Other study ID #: 2010.116.C
• Secondary ID: PI-Osteen
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2010
• Last updated: March 20, 2014
• Start date: October 2010
• Est. completion date: October 2016

Study information

• Verified date: March 2014
• Source: Ochsner Health System
• Contact: Kristie Osteen, MD
• Phone: 504-842-3755
• Email: kosteen[@]ochsner.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare ultrasound and predetermined distance techniques for finding the paravertebral space to inject the local anesthetic (numbing medicine) when you are given anesthesia for surgery. The paravertebral space is located on either side of the spinal cord and contains the nerves that provide sensation to the chest wall. The predetermined distance technique is a series of measurements taken to determine the location of the paravertebral space where the local anesthetic is injected. The ultrasound technique uses direct visualization of the local anesthetic being placed in the paravertebral space. This type of anesthesia has many benefits including decreasing your pain after breast surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria:

• Females age 25 - 85

• ASA Physical status I-III

• Scheduled for primary mastectomy

• Ability to give informed consent

Exclusion Criteria:

• Allergy to:

Local anesthetics Fentanyl Hydromorphone Propofol Midazolam

• Patient refusal

• Infection at the injection site

• Peripheral Neuropathy

• Bilateral breast surgery

• Prior thoracic surgery on surgical side

• Severe spinal deformity

• Coagulopathy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Neoplasms
• Mastectomy

Intervention

Procedure:
• ultrasound
Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
• predetermined distance
The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

Country where clinical trial is conducted

United States, 

References & Publications (9)

Boughey JC, Goravanchi F, Parris RN, Kee SS, Kowalski AM, Frenzel JC, Bedrosian I, Meric-Bernstam F, Hunt KK, Ames FC, Kuerer HM, Lucci A. Prospective randomized trial of paravertebral block for patients undergoing breast cancer surgery. Am J Surg. 2009 N — View Citation

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. — View Citation

Deegan CA, Murray D, Doran P, Ecimovic P, Moriarty DC, Buggy DJ. Effect of anaesthetic technique on oestrogen receptor-negative breast cancer cell function in vitro. Br J Anaesth. 2009 Nov;103(5):685-90. doi: 10.1093/bja/aep261. Epub 2009 Sep 22. Erratum — View Citation

Domingo-Triadó V, Selfa S, Martínez F, Sánchez-Contreras D, Reche M, Tecles J, Crespo MT, Palanca JM, Moro B. Ultrasound guidance for lateral midfemoral sciatic nerve block: a prospective, comparative, randomized study. Anesth Analg. 2007 May;104(5):1270- — View Citation

Goldfarb Y, Ben-Eliyahu S. Surgery as a risk factor for breast cancer recurrence and metastasis: mediating mechanisms and clinical prophylactic approaches. Breast Dis. 2006-2007;26:99-114. Review. — View Citation

la Grange P, Foster PA, Pretorius LK. Application of the Doppler ultrasound bloodflow detector in supraclavicular brachial plexus block. Br J Anaesth. 1978 Sep;50(9):965-7. — View Citation

Marhofer P, Schrögendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7. — View Citation

Oberndorfer U, Marhofer P, Bösenberg A, Willschke H, Felfernig M, Weintraud M, Kapral S, Kettner SC. Ultrasonographic guidance for sciatic and femoral nerve blocks in children. Br J Anaesth. 2007 Jun;98(6):797-801. Epub 2007 Apr 21. — View Citation

Willschke H, Marhofer P, Bösenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 Aug;95(2):226-30. Epub 2005 May 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scores(VAS)for pain and perioperative opioid requirements	The VAS scores and the opioid consumption will be compared between the ultrasound group and the predetermined distance technique group.	24 hours	No
Secondary	time, incidence of adverse events and patient satisfaction	The secondary objectives will be 1) time taken to locate the paravertebral space and inject local anesthetic 2) time from injection of local anesthetic to adequate sensory block 3) incidence of adverse events including pneumothorax, high spinal, epidural spread, direct nerve damage, paresthesias, vascular puncture, patient discomfort, respiratory depression, hypoxemia, and prolonged sensory blockade and 4) patient satisfaction.	24 hours	Yes

External Links

•   Click here for more information about this study: A comparison between to methods of locating the nerve space for local anesthestic injection in women having breast surgery