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 range65 Years – 85 Years

SexALL

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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).
✕. Chronic opioid use of ≥ 20 morphine milligram equivalent (MME)/day for more than 7 days in the last 30 days.

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