Study 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
Primary Objective |
To compare total opioid consumption in morphine equivalents following fascia iliaca compartment block (FICB) with EXPAREL® (bupivacaine liposome injectable suspension) +bupivacaine HCl to that following continuous infusion of ropivacaine via catheter, from end of FICB placement through 72 hours post-FICB, in subjects undergoing repair of intertrochanteric hip fracture.
Study Status: Recruiting
NCT Number: NCT03955458
Study Nickname: RESTORE
Target Number of Sites: 3
Key Participation Criteria
Maximum of 19 days
- 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.
- Hip fracture that requires total arthroplasty.
- Patients transferred from other hospitals.
- Patients who 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 (eg, 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.
- Body Mass Index (BMI) <17 kg/m2 or >45 kg/m2.
- Known history of renal or hepatic dysfunction, coagulation, or bleeding disorder.
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the postsurgical period for pain that is not strictly related to the surgery and that may confound the postsurgical assessments based on the physician’s discretion.
- Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study.
- History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject’s participation in this study.
- Previous participation in an EXPAREL study.
- Resident of a skilled nursing facility (SNF), long-term acute care (LTAC) facility, inpatient rehabilitation facility (IRF), or nursing home. Participants from assisted living facilities will be eligible for the study.
- In addition, the subject may be withdrawn from the study if the subject meets the following criteria during the hospital stay:
- Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject’s postsurgical course.
- Subjects who undergo hip fracture surgery more than 30 hours after admission to the Emergency Department.