Femoral FracturesPhase 2NCT02679560
Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures
A Phase 2 study testing Liposomal Bupivacaine and Ropivacaine HCL in people with Femoral Fractures, run by Ian Elliott Brown at 1 site in United States.
Trial summary
This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- Liposomal Bupivacaine and Ropivacaine HCL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years ≤ 70 years
- Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital
- Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident.
Who cannot join
- >10 hours since presentation to the emergency department
- History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.
- Central or peripheral neurologic deficit on presentation
- Concern or compartment syndrome
- Associated additional long bone fractures
- End stage liver failure
Show all 18Show fewer
- Renal failure requiring dialysis
- Pregnancy or breast feeding
- Prisoners
- Coagulopathy with INR >1.5
- Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)
- Suspected prolonged intubation within first 12 hours secondary to respiratory failure other than peri-procedurally
- Adults unable to consent
- Pediatric patients <18 years old
- Patients exhibiting signs of shock upon admission, HR >120 or SBP <100 mmHg.
- History of allergic reaction to local anesthetics
- Administration of any other local anesthetic in the 2 hours prior to the study enrollment.
- Distal femur fractures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Med Center- Trauma and Acute Care Surgery
Sacramento, California, 95817
About this study
Official title: Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial
This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.
Read the detailed description
In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will result in less total opioid administration during the randomization period compared to a fascia iliaca compartment block using 0.2% ropivacaine.
The long-term goal of this study is to provide pilot information to guide and design larger, multicenter trials which will evaluate the utility and cost-effectiveness of long acting liposomal bupivacaine as an opioid-sparring analgesic strategy in injured trauma patients. Ultimately, it is hoped that this information can improve safe and effective narcotic sparing analgesia in the awake, combat casualty, as well as serve as primary steps towards
- Conditions
- Femoral Fractures
- Being tested
- Liposomal Bupivacaine, Ropivacaine HCL
- Keywords
- femur fracture, hip fracture, exparel, liposomal bupivacaine
- Medical subject headings
- Femoral Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
Also called Exparel®
A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine
Ropivacaine HCLDrug
Also called Naropin (trade name)
Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered Receives: Drug: Liposomal Bupivacaine |
| Ropivacaine HCL | Placebo comparator | In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered Receives: Drug: Ropivacaine HCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Requirements
Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents
Measured: Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.
Secondary outcomes (1)
Patient Outcomes
Total daily opioid requirements for days 1-3, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay
Measured: Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study start1 Oct 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Femoral 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ian Elliott Brown
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Ian Elliott Brown, University of California, Davis
- Investigators
- Ian Brown, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679560
- Sponsor's protocol ID
- 782382
- Other IDs
- D6.715L15J91110
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2016
- Last updated
- 21 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial
- ClinicalTrials.gov ID
- NCT02679560
- Acronym / sponsor ID
- 782382
- Conditions
- Femoral Fractures
- Keywords
- femur fracture, hip fracture, exparel, liposomal bupivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Ian Elliott BrownUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 10 Feb 2016 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated, single-center, randomized, patient blinded, controlled trial. The purpose of this study is to compare the effect of a fascia iliaca compartment block (FICB) using 0.2% ropivacaine vs. liposomal bupivacaine in patients with femur and/or hip fractures admitted to the University of California Davis Medical Center (UCDMC). The primary endpoint will be the total opioid requirements during the 96 hour randomization period with secondary endpoints including total daily opioid requirements for days 1-4, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay.
Detailed description
In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will result in less total opioid administration during the randomization period compared to a fascia iliaca compartment block using 0.2% ropivacaine.
The long-term goal of this study is to provide pilot information to guide and design larger, multicenter trials which will evaluate the utility and cost-effectiveness of long acting liposomal bupivacaine as an opioid-sparring analgesic strategy in injured trauma patients. Ultimately, it is hoped that this information can improve safe and effective narcotic sparing analgesia in the awake, combat casualty, as well as serve as primary steps towards
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Active comparator | Drug: Liposomal BupivacaineIn patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered |
| Ropivacaine HCL | Placebo comparator | Drug: Ropivacaine HCLIn patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years ≤ 70 years
- Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital
- Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident.
Key exclusion criteria (18 listed)
- >10 hours since presentation to the emergency department
- History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.
- Central or peripheral neurologic deficit on presentation
- Concern or compartment syndrome
- Associated additional long bone fractures
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 |
|---|---|---|
| Liposomal BupivacaineAlso: Exparel®A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine | Drug | Liposomal Bupivacaine |
| Ropivacaine HCLAlso: Naropin (trade name)Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally. | Drug | Ropivacaine HCL |
Primary outcome
Opioid Requirements
Time frame: Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.
Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents
1 secondary outcome
Patient Outcomes
Time frame: Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ian Brown, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Bupivacaine and Ropivacaine HCL in people with Femoral Fractures, run by Ian Elliott Brown 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 18 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: stopped early, as of the sponsor's last update on 21 Feb 2021. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioid Requirements (time frame: Assessment time frame will be the initial 96 hours of inpatient status after study drug administration with a daily assessment of total daily opioid requirements and objective pain scores using the numeric rating scale.). 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 21 Feb 2021.