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

March 20, 2014 updated by: Kristie Osteen, Ochsner Health System

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ultrasound
Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Procedure: ultrasound
Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Active Comparator: predetermined distance
The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Procedure: predetermined distance
The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scores(VAS)for pain and perioperative opioid requirements
Time Frame: 24 hours
The VAS scores and the opioid consumption will be compared between the ultrasound group and the predetermined distance technique group.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time, incidence of adverse events and patient satisfaction
Time Frame: 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Principal Investigator: Kristie Osteen, MD, Ochsner Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010.116.C
  • PI-Osteen (Other Identifier: Ochnser Clinic Foundation Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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