WithdrawnPhase 4

EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture

Stopped: Recruitment difficulties

United States0Started 2019-08-26

Plain-language 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.

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Individuals between 65 and 85 years of age (inclusive of) at screening.
. Intertrochanteric femoral fractures with American Society of Anesthesiology physical status 1, 2, or 3.
. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion criteria

. Hip fracture that requires total arthroplasty.
. Patients transferred from other hospitals.
. Patients that have other acute fractures.
. Pre-existing dementia (Mini-Mental State examination score \<20) or delirium (Mini-Mental State examination score \<24).
. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine, ropivacaine, acetaminophen, NSAIDs).
. Serious systemic comorbidities that cause a contraindication for EXPAREL/bupivacaine (severe hepatic or renal impairment) or ropivacaine.
. Use of anticoagulants (including aspirin, except low dose aspirin).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary objective (total opioid consumption in morphine equivalents)

Timeframe: Through 72 hours post-FICB

Trial details

NCT IDNCT03955458

SponsorPacira Pharmaceuticals, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05

View on ClinicalTrials.gov More Hip Fractures trials