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

Not Applicable

• Conditions: Mastectomy; Breast Neoplasms
• Interventions: Procedure: ultrasound; Procedure: predetermined distance

• Registration Number: NCT01217593
• Lead Sponsor: Ochsner Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-20
• Last Update Posted: 2014-03-21
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound	ultrasound	Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
predetermined distance	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 Measures

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

Secondary Outcome Measures

Name	Time	Method
time, incidence of adverse events and patient satisfaction	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.

Trial Locations

Locations (1)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States