Infrared Thermography for Assessment of Caudal Block in Children

Study Overview
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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.

Official Title
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A Clinical Evaluation Of Infrared Thermography To Assess Successful Caudal Block In Children

Conditions
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Anesthesia, Conduction

Intervention / Treatment
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* Device: FLIR ONE
* Procedure: Regional Anesthesia - Caudal Nerve Block


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal<br>Participants receiving a caudal neuraxial blockade, as clinically indicated. | Device: FLIR ONE<br>* Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.<br>Procedure: Regional Anesthesia - Caudal Nerve Block<br>* Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.<br>|
| Sham Comparator: No Caudal<br>Participants not receiving a caudal neuraxial blockade, as clinically indicated. | Device: FLIR ONE<br>* Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of FLIR ONE | Reviewers blinded to intervention groups will asses patient pre-caudal, 1, 2, 3, 4, and 5 minute post-caudal images and rate whether, based on the image, they believe the patient received a caudal or not. The sensitivity and specificity of the FLIR ONE as a diagnositic tol will then be determined. | Assessments will be done through study completion, an average of 1 week following procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter- and Intra- rater reliability | Reviewers will evaluate patient image at two separate ties at least a week apart. Recorded images will be compared within and between reviewers. | Assessments will be done through study completion, an average of 1 week following procedure. | 
| Temperature differences between pre-caudal and 5 minute post-caudal images | Temperature differences between pre-caudal and 5 minute images will be summarized in both groups. Images in the non-caudal group will be taken at similar time points following anesthesia induction relative to caudal group patients. | Images will be captured prior to caudal and 5 minutes immediately afterwards. Assessments will be done through study completion, an average of 1 week following procedure. |