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

Phase 2

Terminated

Brief 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. 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine	Liposomal Bupivacaine	In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered
Ropivacaine HCL	Ropivacaine HCL	In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered

Primary Outcome Measures

Name	Time	Method
Opioid Requirements	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

Secondary Outcome Measures

Name	Time	Method
Patient Outcomes	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 daily opioid requirements for days 1-3, duration of effect and objective pain scores using the numeric rating scale (NRS) during their hospital stay