Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Conduction
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: Paravertebral Block

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Outpatient Surgical and Imaging Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Peripheral Nerve Block with 2 Techniques	Procedure: Erector Spinae Plane Block; Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles; Procedure: Paravertebral Block; Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Temperature Increase From Baseline	Thermography-measured increase in temperature of skin affected by nerve block	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Skin Temperature	Thermography-measured temperature of skin affected by nerve block	30 minutes

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Mary Billstrand, MD, University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): August 23, 2021
• Study Completion (Actual): August 23, 2021

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Erector Spinae Plane block; Paravertebral nerve block
• Other Study ID Numbers: 21-104 Billstrand

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No