Thermographic Imaging in Epidural Anesthesia

Withdrawn

• Conditions: Epidural Blockade
• Interventions: Device: Thermographic imaging

• Registration Number: NCT02739776
• Lead Sponsor: Cook County Health

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

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 Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-15
• Primary Completion: 2017-11-17
• Study Completion: 2017-11-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Thermographic imaging	Pt receiving standard Epidural block care for vaginal delivery

Primary Outcome Measures

Name	Time	Method
Change in temperature in the lower extremities	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.

Secondary Outcome Measures

Name	Time	Method
Successful epidural blockade	up to 30 min after performing the epidural block	adequate sensory level, pain control, motor blockade as evaluated by care provider
Epidural blockade failure	Up to 30 min after performing the epidural block	Failure of the epidural block to adequately control pain, unilateral blockade, optimal sensory level, inadequate motor blockade
Requirement for Epidural catheter manipulation or replacement	Up to 30 min after performing the epidural block