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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mastectomy, Breast Neoplasms

Intervention / Treatment
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* Procedure: ultrasound
* Procedure: predetermined distance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultrasound<br>Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy. | Procedure: ultrasound<br>* Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.<br>|
| Active Comparator: predetermined distance<br>The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy. | Procedure: predetermined distance<br>* The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scores(VAS)for pain and perioperative opioid requirements | The VAS scores and the opioid consumption will be compared between the ultrasound group and the predetermined distance technique group. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time, incidence of adverse events and patient satisfaction | 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. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mastectomy, breast cancer, breast surgery