Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-04-03 @ 12:22 AM
Study NCT ID:
NCT03087604
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2017-03-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Loss of Resistance, w/wo Stimulation, For Epidural Placement
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Loss of Resistance With Nerve Stimulation Versus Loss of Resistance Alone; Effect on Success of Thoracic Epidural Placement.
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
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:
The purpose of this randomized, observer-blinded, investigative trial is to determine if the use of electrical stimulation, compared to the traditional loss of resistance technique alone, improves the success rate of epidural catheter placement at an academic teaching institution.
Detailed Description:
All subjects will receive a thoracic epidural catheter placement at the level appropriate for their surgery and will be randomized to either have the epidural placed with a loss of resistance technique alone or loss of resistance technique with confirmation by nerve stimulation. In the traditional loss of resistance technique group, the epidural catheter will be placed after achieving loss of resistance to air. In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall. Nerve stimulation will be started at a pulse width of 0.3 ms and a frequency of 1 Hz and a current of 0.2mA.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: