Early Detection of Epidural Onset by Temperature Change

Not Applicable

• Conditions: Early Confirmation of Epidural Catheterization
• Interventions: Drug: epidural injection

• Registration Number: NCT02838056
• Lead Sponsor: Taipei Medical University WanFang Hospital

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

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-15
• Study First Posted: 2016-07-20
• Study Start: 2017-02-21
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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
• Trauma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
epidural injection	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)

Primary Outcome Measures

Name	Time	Method
measurement of skin temperature change over big toe after epidural local anesthetic injection	within 10 mins after injection	SPECTRUM 9000MB to detect lower limb color changes

Secondary Outcome Measures

Name	Time	Method
measurement of skin sensation change between inguinal area to umbilicus	within 15 mins after injection	tested by alcohol sponge

Trial Locations

Locations (1)

Taipei Medical University/Wan Fang Hospital; 🇨🇳 Taipei, Taiwan