Thermographic Imaging in Epidural Anesthesia

Epidural Blockade Clinical Trial

Official title:

Infrared Thermographic Imaging for Early Assessment of Epidural Block Success in Obstetric Anesthesia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02739776
• Other study ID #: IRB# 16-012
• Status: Withdrawn
• Start date: February 2, 2016
• Est. completion date: November 17, 2017

Study information

• Verified date: June 2023
• Source: Cook County Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 17, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Epidural Blockade

Intervention

Device:
• Thermographic imaging
Using infrared-recording camera will obtain thermographic images of the lower extremities before and after the epidural blockade

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cook County Health

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Peri-procedural Complications		participants will be followed for the duration of anesthesia and after the procedure, an expected average of 12 hours
Primary	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	Successful epidural blockade	adequate sensory level, pain control, motor blockade as evaluated by care provider	up to 30 min after performing the epidural block
Secondary	Epidural blockade failure	Failure of the epidural block to adequately control pain, unilateral blockade, optimal sensory level, inadequate motor blockade	Up to 30 min after performing the epidural block
Secondary	Requirement for Epidural catheter manipulation or replacement		Up to 30 min after performing the epidural block