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

Ochsner Health System

Status: Unknown

Conditions: Mastectomy; Breast Neoplasms

Treatments: Procedure: ultrasound; Procedure: predetermined distance

Study type: Interventional

Funder types: Other

Identifiers

NCT01217593

PI-Osteen (Other Identifier)

2010.116.C

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 25 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

ultrasound

Experimental group

Description:

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

Treatment:

Procedure: ultrasound

predetermined distance

Active Comparator group

Description:

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

Treatment:

Procedure: predetermined distance