Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833296
Status:
UNKNOWN
Last Update Posted:
2021-04-06
First Post:
2021-03-31
Brief Title:
Ropivacaine Use in Interscalene Block What is the Minimal Effective Analgesic Concentration MEAC 90
Sponsor:
Healthpoint Hospital
Organization:
Healthpoint Hospital
Study Overview
Official Title:
Ropivacaine Use in Interscalene 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:
This study aim to calculate the minimal effective ropivacaine concentration required achieve successful analgesic interscalene block in 90 of patients MEAC90
Detailed Description:
Before induction of general anesthesia all patients will receive interscalene block using 15ml of ropivacaine which concentration will be based on the response of the previous patient
Based on biased-coin design up-down sequential method if patient has pain free recovery a successful block the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 001 wv less However if he has an unsuccessful block the next patient will receive a concentration 001 wv higher
Patients with pain free recovery will be considered to have positive response
Patients responses will be analyzed to calculate the MEAC90
Based on biased-coin design up-down sequential method if patient has pain free recovery a successful block the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 001 wv less However if he has an unsuccessful block the next patient will receive a concentration 001 wv higher
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?:
None
Is an FDA AA801 Violation?:
None