NCT03955458

EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture

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• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Fractures
• Intertrochanteric Fractures

Interventions

Type	Name	Description
DRUG	EXPAREL	FICB with EXPAREL + Bupivacaine HCL (single dose)
DRUG	Ropivacaine	FICB with continuous infusion of ropivacaine
DRUG	Bupivacaine Hydrochloride	FICB with EXPAREL + Bupivacaine HCL (Single dose)

Timeline

• Start date: 2019-08-26
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2019-05-20
• Last updated: 2020-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study