Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures
Condition: Femoral Fractures
MeSH terms: Acute Pain; Fractures, Bone; Femoral Fractures
Intervention: Liposomal Bupivacaine; Ropivacaine HCL
Intervention description: 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 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.
Intervention MeSH terms: Bupivacaine; Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: femur fracture, hip fracture, exparel, liposomal bupivacaine

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. age ≥18 years ≤ 70 years

          2. Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned
             admission to the hospital

          3. Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to
             incident.

        Exclusion Criteria:

          1. >10 hours since presentation to the emergency department

          2. History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.

          3. Central or peripheral neurologic deficit on presentation

          4. Concern or compartment syndrome

          5. Associated additional long bone fractures

          6. End stage liver failure

          7. Renal failure requiring dialysis

          8. Pregnancy or breast feeding

          9. Prisoners

         10. Coagulopathy with INR >1.5

         11. Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran
             etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)

         12. Suspected prolonged intubation within first 12 hours secondary to respiratory failure
             other than peri-procedurally

         13. Adults unable to consent

         14. Pediatric patients <18 years old

         15. Patients exhibiting signs of shock upon admission, HR >120 or SBP <100 mmHg.

         16. History of allergic reaction to local anesthetics

         17. Administration of any other local anesthetic in the 2 hours prior to the study
             enrollment.

         18. Distal femur fractures