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Trial Title:
Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery
NCT ID:
NCT01217593
Condition:
Mastectomy
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
mastectomy
breast cancer
breast surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
ultrasound
Description:
Ultrasound guidance will be used for paravertebral space localization when performing
paravertebral blocks on females 25-85 having unilateral mastectomy.
Arm group label:
ultrasound
Intervention type:
Procedure
Intervention name:
predetermined distance
Description:
The predetermined distance technique will be used for paravertebral space localization
when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Arm group label:
predetermined distance
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:
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
Gender:
Female
Minimum age:
25 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ochsner Clinic Foundation
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristie Osteen, MD
Phone:
504-842-3755
Email:
kosteen@ochsner.org
Contact backup:
Last name:
Heather Porter, BA
Phone:
504-842-4812
Email:
hporter@ochsner.org
Start date:
October 2010
Completion date:
October 2016
Lead sponsor:
Agency:
Ochsner Health System
Agency class:
Other
Source:
Ochsner Health System
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01217593
