Infrared Thermography for Assessment of Caudal Block in Children

Not Applicable

Completed

• Conditions: Anesthesia, Conduction
• Interventions: Device: FLIR ONE; Procedure: Regional Anesthesia - Caudal Nerve Block

• Registration Number: NCT02907957
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-09
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-20
• Primary Completion: 2018-06
• Study Completion: 2018-06-28
• Status Verified: 2018-07
• Last Update Submitted: 2019-08-16
• Last Update Posted: 2019-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal	FLIR ONE	Participants receiving a caudal neuraxial blockade, as clinically indicated.
Caudal	Regional Anesthesia - Caudal Nerve Block	Participants receiving a caudal neuraxial blockade, as clinically indicated.
No Caudal	FLIR ONE	Participants not receiving a caudal neuraxial blockade, as clinically indicated.

Primary Outcome Measures

Name	Time	Method
Predictive value of FLIR ONE	Assessments will be done through study completion, an average of 1 week following procedure.	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.

Secondary Outcome Measures

Name	Time	Method
Inter- and Intra- rater reliability	Assessments will be done through study completion, an average of 1 week following procedure.	Reviewers will evaluate patient image at two separate ties at least a week apart. Recorded images will be compared within and between reviewers.
Temperature differences between pre-caudal and 5 minute post-caudal images	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.	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.

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States