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Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery
Conditions
Mastectomy - Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
mastectomy, breast cancer, breast surgery
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: ultrasound
Type: Procedure
Name: predetermined distance
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 25 Years
Gender: Female
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
- 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
Location
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Status: Recruiting
Contact: Kristie Osteen, MD - 504-842-3755 - kosteen@ochsner.org
Start Date
October 2010
Completion Date
October 2016
Sponsors
Ochsner Health System
Source
Ochsner Health System
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page