Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04834440
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-03-31
Brief Title:
Ropivacaine Use in Femoral Nerve Block What is the Minimal Effective Analgesic Concentration MEAC 90
Sponsor:
Healthpoint Hospital
Organization:
Healthpoint Hospital
Study Overview
Official Title:
Ropivacaine Use in Femoral Nerve Block What is the Minimal Effective Analgesic Concentration MEAC 90
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_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:
The aim of this study is to determine the minimal effective ropivacaine concentration required to provide adequate analgesic femoral nerve block in 90 of patients MEAC90
Detailed Description:
Before induction of GA all patients will receive sciatic obturator lateral femoral cutaneous and femoral nerve blocks
The femoral nerve block will be performed using 15ml of ropivacaine which concentration relied on the response of the previous patient
Based on biased-coin design up-down sequential method when a patient has a negative response the next patient will receive a concentration 001 wv higher However if he has a positive response the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 001 wv less
Patients with pain free recovery will be considered to have positive response
Patients responses will be analyzed to calculate the MEAC90
The femoral nerve block will be performed using 15ml of ropivacaine which concentration relied on the response of the previous patient
Based on biased-coin design up-down sequential method when a patient has a negative response the next patient will receive a concentration 001 wv higher However if he has a positive response the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 001 wv less
Patients with pain free recovery will be considered to have positive response
Patients responses will be analyzed to calculate the MEAC90
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None