Recruiting

Ultrasound vs. Distance

Sponsor:

Ochsner Health System

Code:

NCT01217593

Conditions

Mastectomy

Breast Neoplasms

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

ultrasound

predetermined distance

Study Details

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.

Conditions

Mastectomy

Breast Neoplasms

Study ID

NCT01217593

Start date

Oct, 2010

Status verified date

Mar, 2014

Completion date

Oct, 2016

Anticipated

Primary completion date

Oct, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Visual analog scores(VAS)for pain and perioperative opioid requirements [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Kristie Osteen, MD

504-842-3755kosteen@ochsner.org

Heather S Porter, BA

504-842-4812hporter@ochsner.org

Locations

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Kristie Osteen, MD

504-842-3755kosteen@ochsner.org

Heather Porter, BA

504-842-4812hporter@ochsner.org

More Information

Sponsor

Ochsner Health System

Last update posted

Mar 21, 2014

Last verified

Mar, 2014

Keywords

  • mastectomy
  • breast cancer
  • breast surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ochsner Health System on 2014-03-21.