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Completed

NCT Number: NCT02907957

Infrared Thermography for Assessment of Caudal Block in Children

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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Key information

Conditions

Anesthesia, Conduction

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60613, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLIR One

Device

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

Regional Anesthesia - Caudal Nerve Block

Procedure

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

Primary outcomes

  1. Predictive value of FLIR ONE

    Time frame: 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 outcomes

  1. Inter- and Intra- rater reliability

    Time frame: 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.

  2. Temperature differences between pre-caudal and 5 minute post-caudal images

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2016
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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