Anesthesia, Conduction
Conditions
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 main objective of this study is to evaluate whether a significant change in distal skin temperature (measured at the feet) after caudal block placement can be detected by device users and to evaluate whether these changes can be reliably measured by users as a surrogate marker to predict presence of a caudal block.
Interventions
DEVICEFLIR ONE
Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.
PROCEDURERegional Anesthesia - Caudal Nerve Block
Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.
Sponsors
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLuis Sequera-Ramos, MD
Ann & Robert H Lurie Children's Hospital of Chicago
Outcome results
None listed