Epidural BlockadeNCT02739776
Thermographic Imaging in Epidural Anesthesia
An observational study of Epidural Blockade, run by Cook County Health.
Trial summary
The purpose of this study is to describe infrared thermographic imaging as a tool for the assessment of epidural block in obstetrics patients Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Epidural Blockade
- What is being tested?
- Thermographic imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2016to 17 Nov 2017
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parturients in active labor, older than18 year of age, requesting epidural anesthesia for normal vaginal delivery
Who may be able to join
- Parturients in active labor requesting epidural anesthesia for normal vaginal delivery
Who cannot join
- Patients with lower extremity skin disorders like active infections like cellulitis, ,dermatitis, psoriasis or connective tissue disorders like scleroderma or Raynaud's phenomenon
- Patients with diagnosed peripheral vascular disease ,venous stasis , deep venous thrombosis.
- Patients with Severe preeclampsia with significant lower extremity edema
- Patient on vasoactive agents like vasodilators, calcium channels blockers.
About this study
Official title: Infrared Thermographic Imaging for Early Assessment of Epidural Block Success in Obstetric Anesthesia
The purpose of this study is to describe infrared thermographic imaging as a tool for the assessment of epidural block in obstetrics patients
Read the detailed description
Patients will recive standard anesthesia care for epidural placement and additionally, thermographic imaging will be obtained at baseline and up to 30 min after the epidural blockade is performed.
- Conditions
- Epidural Blockade
- Being tested
- Thermographic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermographic imagingDevice
Using infrared-recording camera will obtain thermographic images of the lower extremities before and after the epidural blockade
| Study group | Role | What they receive |
|---|---|---|
| A | Pt receiving standard Epidural block care for vaginal delivery Receives: Device: Thermographic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in temperature in the lower extremities
thermographic images of the lower extremities will be obtained and analyzed for thermography patterns.
Measured: at baseline, 5 min before the epidural blockade, during and up to 30 minutes after performing the epidural blockade
Secondary outcomes (3)
Successful epidural blockade
adequate sensory level, pain control, motor blockade as evaluated by care provider
Measured: up to 30 min after performing the epidural block
Epidural blockade failure
Failure of the epidural block to adequately control pain, unilateral blockade, optimal sensory level, inadequate motor blockade
Measured: Up to 30 min after performing the epidural block
Requirement for Epidural catheter manipulation or replacement
Measured: Up to 30 min after performing the epidural block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start2 Feb 2016
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Why it stopped: incomplete information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epidural BlockadeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pamela Gonzalez Sr Director Clinical Research Office, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739776
- Sponsor's protocol ID
- IRB# 16-012
- Status last verified
- Jun 2023
- First submitted
- 29 Mar 2016
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Galvin EM, Niehof S, Medina HJ, Zijlstra FJ, van Bommel J, Klein J, Verbrugge SJ. Thermographic temperature measurement compared with pinprick and cold sensation in predicting the effectiveness of regional blocks. Anesth Analg. 2006 Feb;102(2):598-604. doi: 10.1213/01.ane.0000189556.49429.16.
PubMed 16428569Kim YC, Bahk JH, Lee SC, Lee YW. Infrared thermographic imaging in the assessment of successful block on lumbar sympathetic ganglion. Yonsei Med J. 2003 Feb;44(1):119-24. doi: 10.3349/ymj.2003.44.1.119.
PubMed 12619184Asghar S, Lundstrom LH, Bjerregaard LS, Lange KH. Ultrasound-guided lateral infraclavicular block evaluated by infrared thermography and distal skin temperature. Acta Anaesthesiol Scand. 2014 Aug;58(7):867-74. doi: 10.1111/aas.12351. Epub 2014 Jun 12.
PubMed 24924688
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infrared Thermographic Imaging for Early Assessment of Epidural Block Success in Obstetric Anesthesia
- ClinicalTrials.gov ID
- NCT02739776
- Acronym / sponsor ID
- IRB# 16-012
- Conditions
- Epidural Blockade
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: incomplete information
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 15 Apr 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.
The purpose of this study is to describe infrared thermographic imaging as a tool for the assessment of epidural block in obstetrics patients
Detailed description
Patients will recive standard anesthesia care for epidural placement and additionally, thermographic imaging will be obtained at baseline and up to 30 min after the epidural blockade is performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Thermographic imagingPt receiving standard Epidural block care for vaginal delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parturients in active labor, older than18 year of age, requesting epidural anesthesia for normal vaginal delivery
Key inclusion criteria (1 listed)
- Parturients in active labor requesting epidural anesthesia for normal vaginal delivery
Key exclusion criteria (4 listed)
- Patients with lower extremity skin disorders like active infections like cellulitis, ,dermatitis, psoriasis or connective tissue disorders like scleroderma or Raynaud's phenomenon
- Patients with diagnosed peripheral vascular disease ,venous stasis , deep venous thrombosis.
- Patients with Severe preeclampsia with significant lower extremity edema
- Patient on vasoactive agents like vasodilators, calcium channels blockers.
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 |
|---|---|---|
| Thermographic imagingUsing infrared-recording camera will obtain thermographic images of the lower extremities before and after the epidural blockade | Device | A |
Primary outcome
Change in temperature in the lower extremities
Time frame: at baseline, 5 min before the epidural blockade, during and up to 30 minutes after performing the epidural blockade
thermographic images of the lower extremities will be obtained and analyzed for thermography patterns.
3 secondary outcomes
Successful epidural blockade
Time frame: up to 30 min after performing the epidural block
Epidural blockade failure
Time frame: Up to 30 min after performing the epidural block
Requirement for Epidural catheter manipulation or replacement
Time frame: Up to 30 min after performing the epidural block
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Background: PubMed 16428569Galvin EM, Niehof S, Medina HJ, Zijlstra FJ, van Bommel J, Klein J, Verbrugge SJ. Thermographic temperature measurement compared with pinprick and cold sensation in predicting the effectiveness of regional blocks. Anesth Analg. 2006 Feb;102(2):598-604. doi: 10.1213/01.ane.0000189556.49429.16.
- Background: PubMed 12619184Kim YC, Bahk JH, Lee SC, Lee YW. Infrared thermographic imaging in the assessment of successful block on lumbar sympathetic ganglion. Yonsei Med J. 2003 Feb;44(1):119-24. doi: 10.3349/ymj.2003.44.1.119.
- Background: PubMed 24924688Asghar S, Lundstrom LH, Bjerregaard LS, Lange KH. Ultrasound-guided lateral infraclavicular block evaluated by infrared thermography and distal skin temperature. Acta Anaesthesiol Scand. 2014 Aug;58(7):867-74. doi: 10.1111/aas.12351. Epub 2014 Jun 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural Blockade, run by Cook County Health.
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 4 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: withdrawn, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in temperature in the lower extremities (time frame: at baseline, 5 min before the epidural blockade, during and up to 30 minutes after performing the epidural blockade). 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 NCT02739776, which also lists 3 linked publications.
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 15 Jun 2023.