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

• Status: Terminated
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ian Elliott Brown; University of California, Davis
• Collaborator: United States Department of Defense
• Treatments: Bupivacaine; Ropivacaine

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