Thermal-Imaging Comparison of Nerve Blocks for Bilateral Mastectomy

NCT ID: NCT04928794

Last Updated: 2024-10-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2021-08-23

Brief Summary

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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

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Conditions

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Anesthesia, Conduction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peripheral Nerve Block with 2 Techniques

Group Type OTHER

Erector Spinae Plane Block

Intervention Type PROCEDURE

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

Paravertebral Block

Intervention Type PROCEDURE

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

Interventions

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Erector Spinae Plane Block

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

Intervention Type PROCEDURE

Paravertebral Block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Mary Billstrand

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Billstrand, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico Outpatient Surgical and Imaging Services

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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21-104 Billstrand

Identifier Type: -

Identifier Source: org_study_id

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