Summary

for people ages 18-70 (full criteria)
at Sacramento, California
study started
estimated completion
Scott Zakaluzny

Description

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.

Official Title

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

Details

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

Keywords

Femoral Fractures femur fracture, hip fracture, exparel, liposomal bupivacaine Acute Pain Fractures, Bone Bupivacaine Ropivacaine Liposomal Bupivacaine Ropivacaine HCL

Eligibility

You can join if…

Open to people ages 18-70

  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.

You CAN'T join if...

  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

Location

  • University of California Davis Med Center- Trauma and Acute Care Surgery accepting new patients
    Sacramento California 95817 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ian Elliott Brown
Links
Sign up for this study
ID
NCT02679560
Phase
Phase 2
Study Type
Interventional
Last Updated