Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures

Study Overview
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Brief Summary
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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
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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

Official Title
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Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial

Conditions
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Femoral Fractures

Intervention / Treatment
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* Drug: Liposomal Bupivacaine
* Drug: Ropivacaine HCL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: >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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposomal Bupivacaine<br>In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered | Drug: Liposomal Bupivacaine<br>* A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine<br>* Other names: Exparel®;|
| Placebo Comparator: Ropivacaine HCL<br>In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered | Drug: Ropivacaine HCL<br>* 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.<br>* Other names: Naropin (trade name);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Requirements | Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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femur fracture, hip fracture, exparel, liposomal bupivacaine