Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT03955458
Status:
WITHDRAWN
Last Update Posted:
2020-02-27
First Post:
2019-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture
Sponsor:
Pacira Pharmaceuticals, Inc
Organization:
Study Overview
Official Title:
A Phase-4, Multicenter, Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of EXPAREL When Administered Via Fascia Iliaca Compartment Block Versus Fascia Iliaca Compartment Block With Continuous Infusion of Ropivacaine Per Standard of Care Through a Catheter in Intertrochanteric Hip Fracture Patients
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment difficulties
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE
Brief Summary:
This study evaluates the effect of EXPAREL on total opioid consumption through 72 hours following fascia iliaca compartment block (FICB) in subjects undergoing repair of intertrochanteric hip fracture.
Detailed Description:
The current standard of care treatment for pain relief in patients with intertrochanteric hip fracture is a FICB with continuous infusion of ropivacaine given via catheter.
In this study, some people will receive a single injection FICB with EXPAREL + bupivacaine HCl. The groups will be evaluated to determine the amount of pain medication they took from the FICB to 72 hours after.
In this study, some people will receive a single injection FICB with EXPAREL + bupivacaine HCl. The groups will be evaluated to determine the amount of pain medication they took from the FICB to 72 hours after.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: