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NCT04928794 Clinical Trial

Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy

Anesthesia, Conduction Clinical Trial

Official title:
Dermatomal Spread of Paravertebral and Erector Spinae Plane Nerve Blocks as Compared by Thermal Imaging

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04928794
Other study ID # 21-104 Billstrand
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 19, 2021
Est. completion date August 23, 2021

Study information
Verified date November 2021
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a one-armed trial of two regional anesthesia (peripheral nerve block) techniques to provide postoperative analgesia after bilateral mastectomy. The two techniques are paravertebral block and erector spinae plane (ESP) block. Patients will serve as their own controls, with one block technique applied on one side of the body and the other technique contralaterally. Anatomical distribution of block effectiveness will be assessed with thermal imaging, and this distribution will be visually compared between the two techniques.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date August 23, 2021
Est. primary completion date August 23, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult female patients having bilateral mastectomy surgery at University of New Mexico Outpatient Surgical and Imaging Services (OSIS) facility - Age >18 years - Consenting to regional anesthesia for postoperative pain control Exclusion Criteria: - Age <18 years - Unable to consent - Using anticoagulant medication or have a bleeding disorder - Pregnancy - Inability to speak English for consent process

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Erector Spinae Plane Block
Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles
• Paravertebral Block
Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae

Locations
Country Name City State
United States University of New Mexico Outpatient Surgical and Imaging Services Albuquerque New Mexico

Sponsors (1)
Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anatomical distribution of block effectiveness Thermal imaging-assessed distribution of elevated skin temperature caused by nerve block 30 minutes
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