Thermographic Imaging in Epidural Anesthesia

NCT02739776 | Withdrawn

• 1 other identifier: IRB# 16-012
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to describe infrared thermographic imaging as a tool for the assessment of epidural block in obstetrics patients

Conditions

Epidural Blockade

Outcome Measures

Primary Outcomes (1)

• Change in temperature in the lower extremities

  thermographic images of the lower extremities will be obtained and analyzed for thermography patterns.

  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

  up to 30 min after performing the epidural block

• Epidural blockade failure

  Up to 30 min after performing the epidural block

• Requirement for Epidural catheter manipulation or replacement

  Up to 30 min after performing the epidural block

Other Outcomes (1)

• Peri-procedural Complications

  participants will be followed for the duration of anesthesia and after the procedure, an expected average of 12 hours

Study Arms (1)

A

Pt receiving standard Epidural block care for vaginal delivery

Device: Thermographic imaging

Interventions

Thermographic imaging DEVICE

Using infrared-recording camera will obtain thermographic images of the lower extremities before and after the epidural blockade

A

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parturients in active labor, older than18 year of age, requesting epidural anesthesia for normal vaginal delivery

You may qualify if:

• Parturients in active labor requesting epidural anesthesia for normal vaginal delivery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook County Health: lead

Related Publications (3)

• 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.

  PMID: 16428569 BACKGROUND

• Kim 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.

  PMID: 12619184 BACKGROUND

• Asghar 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.

  PMID: 24924688 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dir Clinical Research

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 15, 2016
• Study Start: February 2, 2016
• Primary Completion: November 17, 2017
• Study Completion: November 17, 2017
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share