Hip FracturesPhase 4RESTORENCT03955458
EXPAREL Facia Iliaca Compartment Block for Intertrochanteric Hip Fracture
A Phase 4 study testing EXPAREL, Ropivacaine and Bupivacaine Hydrochloride in people with Hip Fractures and Intertrochanteric Fractures, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Hip Fractures, Intertrochanteric Fractures
- What is being tested?
- EXPAREL, Ropivacaine and Bupivacaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2019to May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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 (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's post-operative course.
- Subjects who undergo hip fracture surgery more than 30 hours after admission to the Emergency Department.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- EXPAREL, Ropivacaine, Bupivacaine Hydrochloride
- Keywords
- EXPAREL, FICB, Fascia Iliaca Compartment Block, Ropivacaine
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPARELDrug
FICB with EXPAREL + Bupivacaine HCL (single dose)
RopivacaineDrug
FICB with continuous infusion of ropivacaine
Bupivacaine HydrochlorideDrug
FICB with EXPAREL + Bupivacaine HCL (Single dose)
| Study group | Role | What they receive |
|---|---|---|
| FICB with EXPAREL | Experimental | Group 1: Suprainguinal Fascia Iliaca Compartment Block (FICB) with EXPAREL and bupivacaine HCl Receives: 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. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through 72 hours post-FICB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start26 Aug 2019
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nayana Nagaraj, MD, PhD, MPH, Study director, Pacira Biosciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955458
- Sponsor's protocol ID
- 402-C-415
- Acronym
- RESTORE
- Status last verified
- Feb 2020
- First submitted
- 14 May 2019
- Last updated
- 27 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03955458
- Acronym / sponsor ID
- RESTORE / 402-C-415
- Conditions
- Hip Fractures, Intertrochanteric Fractures
- Keywords
- EXPAREL, FICB, Fascia Iliaca Compartment Block, Ropivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FICB with EXPAREL | Experimental | Drug: EXPAREL, Drug: Bupivacaine HydrochlorideGroup 1: Suprainguinal Fascia Iliaca Compartment Block (FICB) with EXPAREL and bupivacaine HCl |
| FICB with Standard of Care: ropivacaine | Active comparator | Drug: RopivacaineSuprainguinal FICB with continuous infusion of local anesthetic (ropivacaine) via catheter placed in the FIC. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXPARELFICB with EXPAREL + Bupivacaine HCL (single dose) | Drug | FICB with EXPAREL |
| RopivacaineFICB with continuous infusion of ropivacaine | Drug | FICB with Standard of Care: ropivacaine |
| Bupivacaine HydrochlorideFICB with EXPAREL + Bupivacaine HCL (Single dose) | Drug | FICB with EXPAREL |
Primary outcome
Primary objective (total opioid consumption in morphine equivalents)
Time frame: Through 72 hours post-FICB
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayana Nagaraj, MD, PhD, MPH study director
Pacira Biosciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EXPAREL, Ropivacaine and Bupivacaine Hydrochloride in people with Hip Fractures and Intertrochanteric Fractures, run by Pacira Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary objective (total opioid consumption in morphine equivalents) (time frame: Through 72 hours post-FICB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.