Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy

Not Applicable

Completed

• Conditions: Anesthesia, Conduction
• Interventions: Procedure: Erector Spinae Plane Block; Procedure: Paravertebral Block

• Registration Number: NCT04928794
• Lead Sponsor: University of New Mexico

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-19
• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-06-15
• Study First Posted: 2021-06-16
• Primary Completion: 2021-08-23
• Study Completion: 2021-08-23
• Results First Submitted: 2023-12-19
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-17
• Last Update Submitted: 2024-10-17
• Results First Posted: 2024-10-21
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral Nerve Block with 2 Techniques	Erector Spinae Plane Block	-
Peripheral Nerve Block with 2 Techniques	Paravertebral Block	-

Primary Outcome Measures

Name	Time	Method
Skin Temperature Increase From Baseline	30 minutes	Thermography-measured increase in temperature of skin affected by nerve block

Secondary Outcome Measures

Name	Time	Method
Average Skin Temperature	30 minutes	Thermography-measured temperature of skin affected by nerve block

Trial Locations

Locations (1)

University of New Mexico Outpatient Surgical and Imaging Services; 🇺🇸 Albuquerque, New Mexico, United States