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Clinical Trials/NCT02838056
NCT02838056
Unknown
Not Applicable

Early Detection of the Effect of Epidural Local Anesthetic by Temperature Change on the Big Toe

Taipei Medical University WanFang Hospital1 site in 1 country40 target enrollmentFebruary 21, 2017

Overview

Phase
Not Applicable
Intervention
epidural injection
Conditions
Early Confirmation of Epidural Catheterization
Sponsor
Taipei Medical University WanFang Hospital
Enrollment
40
Locations
1
Primary Endpoint
measurement of skin temperature change over big toe after epidural local anesthetic injection
Last Updated
9 years ago

Overview

Brief Summary

Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as "loss of resistance" while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Moreover, the onset of sensory block is usually slow, thus making confirmation of catheter position a tough task and may delay the turnover of the operating room. The only way to confirm the catheter position objectively without delaying surgery is to find a reliable indicator within minutes of local anesthetic injection. In this study, we try to use the change of temperature in the big toe as a surrogate indicator of correct epidural catheterization.

Detailed Description

Epidural anesthesia loading dose: 17ml 2% xylocaine + 2.3ml sodium bicarbonate + 2ml Rapifen (1088 mcg) + 0.1 mg epinephrine

Registry
clinicaltrials.gov
Start Date
February 21, 2017
End Date
September 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Body weight:50-90kg,
  • American Society of Anesthesiologists physical status classification I-II,
  • Under epidural anesthesia for surgery

Exclusion Criteria

  • History of receiving lumbar surgery
  • Allergy to alfentanil ,xylocaine, bicarbonate

Arms & Interventions

epidural injection

epidural injection of 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000)

Intervention: epidural injection

Outcomes

Primary Outcomes

measurement of skin temperature change over big toe after epidural local anesthetic injection

Time Frame: within 10 mins after injection

SPECTRUM 9000MB to detect lower limb color changes

Secondary Outcomes

  • measurement of skin sensation change between inguinal area to umbilicus(within 15 mins after injection)

Study Sites (1)

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