Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619340
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
EXPAREL IPSA Block in Knee Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Case Series Assessing the Clinical Utility of EXPAREL As an Intra-articular Posteromedial Surgeon Administered IPSA Block in Patients Undergoing Primary Unilateral Total Knee Arthroplasty
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a case series to assess the clinical utility of an Intra-articular Posteromedial Surgeon Administered IPSA Block in patients undergoing primary unilateral total knee arthroplasty
Detailed Description:
EXPAREL is approved by the Food and Drug Administration FDA for use in adults to produce postsurgical regional analgesia via an adductor canal block The purpose of this study is to evaluate the clinical utility of a surgeon administered EXPAREL adductor canal block intraoperatively in patients undergoing primary unilateral total knee arthroplasty TKA
Patients will not be randomized - all patients will receive an EXPAREL IPSA block intraoperatively Visual Analog Scale patient reported outcomes and patients satisfaction with pain management will be recorded Adverse events will be monitored
Patients will not be randomized - all patients will receive an EXPAREL IPSA block intraoperatively Visual Analog Scale patient reported outcomes and patients satisfaction with pain management will be recorded Adverse events will be monitored
Study Oversight
Has Oversight DMC:
None
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?:
None