Anesthesia, ConductionNCT02907957
Infrared Thermography for Assessment of Caudal Block in Children
An observational study of Anesthesia, Conduction, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Conduction
- What is being tested?
- FLIR ONE and Regional Anesthesia - Caudal Nerve Block
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 28 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children from 6 months of 5 years of age requiring general anesthesia and a caudal block for a surgical procedure.
Who may be able to join
- Children from 6mos to 5 years of age requiring general anesthesia and a caudal block for a surgical procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60613
About this study
Official title: A Clinical Evaluation Of Infrared Thermography To Assess Successful 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 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.
- Conditions
- Anesthesia, Conduction
- Being tested
- FLIR ONE, Regional Anesthesia - Caudal Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLIR ONEDevice
Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.
Regional Anesthesia - Caudal Nerve BlockProcedure or surgery
Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.
| Study group | Role | What they receive |
|---|---|---|
| Caudal | Participants receiving a caudal neuraxial blockade, as clinically indicated. Receives: Device: FLIR ONE; Procedure: Regional Anesthesia - Caudal Nerve Block | |
| No Caudal | Participants not receiving a caudal neuraxial blockade, as clinically indicated. Receives: Device: FLIR ONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessments will be done through study completion, an average of 1 week following procedure.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, ConductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis Sequera-Ramos, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907957
- Sponsor's protocol ID
- IRB 2016-590
- Status last verified
- Oct 2026
- First submitted
- 9 Sep 2016
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25393589
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation Of Infrared Thermography To Assess Successful Caudal Block In Children
- ClinicalTrials.gov ID
- NCT02907957
- Acronym / sponsor ID
- IRB 2016-590
- Conditions
- Anesthesia, Conduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal | – | Device: FLIR ONE, Procedure: Regional Anesthesia - Caudal Nerve BlockParticipants receiving a caudal neuraxial blockade, as clinically indicated. |
| No Caudal | – | Device: FLIR ONEParticipants not receiving a caudal neuraxial blockade, as clinically indicated. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children from 6 months of 5 years of age requiring general anesthesia and a caudal block for a surgical procedure.
Key inclusion criteria (1 listed)
- Children from 6mos to 5 years of age requiring general anesthesia and a caudal block for a surgical procedure
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLIR ONEThermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software. | Device | Caudal, No Caudal |
| Regional Anesthesia - Caudal Nerve BlockNerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries. | Procedure or surgery | Caudal |
Primary outcome
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.
2 secondary outcomes
Inter- and Intra- rater reliability
Time frame: 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 25393589Suresh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Sequera-Ramos, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Conduction, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of FLIR ONE (time frame: Assessments will be done through study completion, an average of 1 week following procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02907957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.