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

Primary Purpose

Mastectomy, Breast Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ultrasound
predetermined distance
Sponsored by
Ochsner Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mastectomy focused on measuring mastectomy, breast cancer, breast surgery

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ochsner Clinic FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ultrasound

predetermined distance

Arm Description

Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.

The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 7, 2010
Last Updated
March 20, 2014
Sponsor
Ochsner Health System
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1. Study Identification

Unique Protocol Identification Number
NCT01217593
Brief Title
Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery
Official Title
A Comparison Of Ultrasound and Predetermined Distance Techniques For Paravertebral Space Localization In Breast Surgery: A Randomized Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ochsner Health System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy, Breast Neoplasms
Keywords
mastectomy, breast cancer, breast surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ultrasound
Arm Type
Experimental
Arm Description
Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Arm Title
predetermined distance
Arm Type
Active Comparator
Arm Description
The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Intervention Type
Procedure
Intervention Name(s)
ultrasound
Intervention Description
Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Intervention Type
Procedure
Intervention Name(s)
predetermined distance
Intervention Description
The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Primary Outcome Measure Information:
Title
Visual analog scores(VAS)for pain and perioperative opioid requirements
Description
The VAS scores and the opioid consumption will be compared between the ultrasound group and the predetermined distance technique group.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
time, incidence of adverse events and patient satisfaction
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristie Osteen, MD
Phone
504-842-3755
Email
kosteen@ochsner.org
First Name & Middle Initial & Last Name or Official Title & Degree
Heather S Porter, BA
Phone
504-842-4812
Email
hporter@ochsner.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristie Osteen, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristie Osteen, MD
Phone
504-842-3755
Email
kosteen@ochsner.org
First Name & Middle Initial & Last Name & Degree
Heather Porter, BA
Phone
504-842-4812
Email
hporter@ochsner.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
708565
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. doi: 10.1093/bja/50.9.965.
Results Reference
background
PubMed Identifier
9322469
Citation
Marhofer P, Schrogendorfer 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. doi: 10.1097/00000539-199710000-00026.
Results Reference
result
PubMed Identifier
17456685
Citation
Domingo-Triado V, Selfa S, Martinez F, Sanchez-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):1270-4, tables of contents. doi: 10.1213/01.ane.0000221469.24319.49.
Results Reference
result
PubMed Identifier
15923270
Citation
Willschke H, Marhofer P, Bosenberg 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. doi: 10.1093/bja/aei157. Epub 2005 May 27.
Results Reference
result
PubMed Identifier
17449890
Citation
Oberndorfer U, Marhofer P, Bosenberg 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. doi: 10.1093/bja/aem092. Epub 2007 Apr 21.
Results Reference
result
PubMed Identifier
19776028
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 In: Br J Anaesth. 2010 Apr;104(4):516.
Results Reference
result
PubMed Identifier
19427625
Citation
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 Nov;198(5):720-5. doi: 10.1016/j.amjsurg.2008.11.043. Epub 2009 May 9.
Results Reference
result
PubMed Identifier
17473369
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. doi: 10.3233/bd-2007-26109.
Results Reference
result
PubMed Identifier
9563536
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. doi: 10.1097/00000658-199804000-00008.
Results Reference
result

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

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