Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy

NCT04928794 | Completed Results

• 1 other identifier: 21-104 Billstrand
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Conduction

Keywords

Paravertebral nerve block; Erector Spinae Plane block

Outcome Measures

Primary Outcomes (1)

• Skin Temperature Increase From Baseline

  Thermography-measured increase in temperature of skin affected by nerve block

  30 minutes

Secondary Outcomes (1)

• Average Skin Temperature

  30 minutes

Study Arms (1)

Peripheral Nerve Block with 2 Techniques

OTHER

Procedure: Erector Spinae Plane Block; Procedure: Paravertebral Block

Interventions

Erector Spinae Plane Block PROCEDURE

Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles

Peripheral Nerve Block with 2 Techniques

Paravertebral Block PROCEDURE

Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae

Peripheral Nerve Block with 2 Techniques

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Unable to consent
• Using anticoagulant medication or have a bleeding disorder
• Pregnancy
• Inability to speak English for consent process

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Outpatient Surgical and Imaging Services

Albuquerque, New Mexico, 87102, United States

Location

Results Point of Contact

• Title: Anesthesiology Research Director
• Organization: Anesthesiology Department, University of New Mexico

HSC-Anesthesiology@salud.unm.edu

505-272-2610

Study Officials

• Mary Billstrand, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 16, 2021
• Study Start: May 19, 2021
• Primary Completion: August 23, 2021
• Study Completion: August 23, 2021
• Last Updated: October 21, 2024
• Results First Posted: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)