NCT02907957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
Last Updated

August 20, 2019

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

September 9, 2016

Last Update Submit

August 16, 2019

Conditions

Anesthesia, Conduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Inter- and Intra- rater reliability

    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

    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.

Study Arms (2)

Caudal

ACTIVE COMPARATOR

Participants receiving a caudal neuraxial blockade, as clinically indicated.

Device: FLIR ONEProcedure: Regional Anesthesia - Caudal Nerve Block

No Caudal

SHAM COMPARATOR

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

Device: FLIR ONE

Interventions

Regional Anesthesia - Caudal Nerve BlockPROCEDURE

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

Caudal
FLIR ONEDEVICE

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

CaudalNo Caudal

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital

Chicago, Illinois, 60613, United States

Location

Related Publications (1)

  • Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446.

    PMID: 25393589BACKGROUND

Study Officials

  • Luis Sequera-Ramos, MD

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Anesthesiology

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 20, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 28, 2018

Last Updated

August 20, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)