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

A Comparison Of Ultrasound and Predetermined Distance Techniques For Paravertebral Space Localization In Breast Surgery: A Randomized Prospective Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01217593

Enrollment

Registered

2010-10-08

Start date

2010-10-31

Completion date

2016-10-31

Last updated

2014-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Mastectomy

Keywords

mastectomy, breast cancer, breast surgery

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.

Interventions

PROCEDUREultrasound

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

PROCEDUREpredetermined distance

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactKristie Osteen, MD

kosteen@ochsner.org504-842-3755

Backup ContactHeather S Porter, BA

hporter@ochsner.org504-842-4812

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026