Infrared Thermography for Assessment of Caudal Block in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-06-28

Brief Summary

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Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients following urological and lower extremity procedures. The injection of local anesthetic into the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a vasodilation, or increased blood flow, to the lower extremities.

The purpose of this study is to determine whether the FLIR ONE thermographic camera, a smartphone attachment which utilizes an application ("app") to measure the temperature at a site on an image of the lower extremity, will be able to differentiate between caudal, non-caudal, and failed caudal images.

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Detailed Description

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Conditions

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Anesthesia, Conduction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Caudal

Participants receiving a caudal neuraxial blockade, as clinically indicated.

Group Type ACTIVE_COMPARATOR

FLIR ONE

Intervention Type DEVICE

Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.

Regional Anesthesia - Caudal Nerve Block

Intervention Type PROCEDURE

Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.

No Caudal

Participants not receiving a caudal neuraxial blockade, as clinically indicated.

Group Type SHAM_COMPARATOR

FLIR ONE

Intervention Type DEVICE

Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.

Interventions

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FLIR ONE

Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.

Intervention Type DEVICE

Regional Anesthesia - Caudal Nerve Block

Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Children from 6mos to 5 years of age requiring general anesthesia and a caudal block for a surgical procedure

Exclusion Criteria

* Patients with preexisting conditions that could affect the skin temperature on the lower extremities such as infection, edema, vascular disorder, etc.
* American Society of Anesthesiologists comorbidity ranking of 4 or greater
* Patient with contraindications for a caudal block such as: history of allergic, reactions to local anesthetics, coagulopathy, infection at the injection site, spinal abnormality, peripheral neurological disease, Raynaud's disease

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes