EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture

NCT03955458 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 402-C-415
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Fractures; Intertrochanteric Fractures

Keywords

EXPAREL; FICB; Fascia Iliaca Compartment Block; Ropivacaine

Outcome Measures

Primary Outcomes (1)

• Primary objective (total opioid consumption in morphine equivalents)

  to compare total opioid consumption in morphine equivalents following FICB with EXPAREL +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 To be measured as date, time, and dosage of all medication administered from the time ICF is signed to 72-hours post-surgery.

  Through 72 hours post-FICB

Study Arms (2)

FICB with EXPAREL

EXPERIMENTAL

Group 1: Suprainguinal Fascia Iliaca Compartment Block (FICB) with EXPAREL and bupivacaine HCl

Drug: EXPAREL; Drug: Bupivacaine Hydrochloride

FICB with Standard of Care: ropivacaine

ACTIVE COMPARATOR

Suprainguinal FICB with continuous infusion of local anesthetic (ropivacaine) via catheter placed in the FIC.

Drug: Ropivacaine

Interventions

EXPAREL DRUG

FICB with EXPAREL + Bupivacaine HCL (single dose)

FICB with EXPAREL

Ropivacaine DRUG

FICB with continuous infusion of ropivacaine

FICB with Standard of Care: ropivacaine

Bupivacaine Hydrochloride DRUG

FICB with EXPAREL + Bupivacaine HCL (Single dose)

FICB with EXPAREL

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 post-operative period for pain that is not strictly related to the surgery and which may confound the post-operative 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nayana Nagaraj, MD, PhD, MPH

  Pacira Biosciences Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 20, 2019
• Study Start: August 26, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: February 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)