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

Stopped early · Phase 2

Conditions studied: Femoral Fractures

In brief

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.

Key facts

Study ID

NCT02679560

Run by

Ian Elliott Brown

People needed

3

Starts

2017-10-01

Expected to finish

2019-11-01

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• >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

Where it is running

• University of California Davis Med Center- Trauma and Acute Care Surgery — Sacramento, California, United States

Full record on ClinicalTrials.gov

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