Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-25 @ 11:02 PM
Study NCT ID:
NCT02838056
Status:
UNKNOWN
Last Update Posted:
2017-02-28
First Post:
2016-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection of Epidural Onset by Temperature Change
Sponsor:
Taipei Medical University WanFang Hospital
Organization:
Study Overview
Official Title:
Early Detection of the Effect of Epidural Local Anesthetic by Temperature Change on the Big Toe
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: