Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-01 @ 10:54 PM
Study NCT ID:
NCT00927368
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of 3 Techniques for Ultrasound-guided Femoral Nerve Catheter Insertion
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
Comparison Between Ultrasound Guided Femoral Nerve Block Versus Ultrasound Guided Femoral Nerve Block With the Use of Peripheral Nerve Stimulation for Patients Undergoing Total Knee Replacement.
Status:
COMPLETED
Status Verified Date:
2017-04
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:
This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.
Detailed Description:
This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.
* Pain Scores after surgery with be measured using the VAS (Visual Analogue Scale). Subjects will be asked to rate their pain on a scale of 1-10.
* Block Performance time is the time from starting the block (after prepping and draping) until catheter is placed.
* Opioid requirements will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used both during surgery, and during the first 48 hours after surgery.
* Block failure rate will be calculated as the rate of cases that requires repeating the block after surgery.
* Pain Scores after surgery with be measured using the VAS (Visual Analogue Scale). Subjects will be asked to rate their pain on a scale of 1-10.
* Block Performance time is the time from starting the block (after prepping and draping) until catheter is placed.
* Opioid requirements will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used both during surgery, and during the first 48 hours after surgery.
* Block failure rate will be calculated as the rate of cases that requires repeating the block after surgery.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: