Clinical trial NCT02739776: Thermographic Imaging in Epidural Anesthesia
Official title: Infrared Thermographic Imaging for Early Assessment of Epidural Block Success in Obstetric Anesthesia
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Epidural Blockade
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2016-04-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients in active labor, older than18 year of age, requesting epidural anesthesia for normal vaginal delivery

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in temperature in the lower extremities
timeFrame: at baseline, 5 min before the epidural blockade, during and up to 30 minutes after performing the epidural blockade
Secondary outcomes:
measure: Successful epidural blockade
timeFrame: up to 30 min after performing the epidural block
measure: Epidural blockade failure
timeFrame: Up to 30 min after performing the epidural block
measure: Requirement for Epidural catheter manipulation or replacement
timeFrame: Up to 30 min after performing the epidural block
Other outcomes:
measure: Peri-procedural Complications
timeFrame: participants will be followed for the duration of anesthesia and after the procedure, an expected average of 12 hours
Locations:
Study officials:
References:
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.
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.
citation: 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.