Clinical trial NCT02679560: Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures
Official title: Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Femoral Fractures
Keywords: femur fracture, hip fracture, exparel, liposomal bupivacaine
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-02-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Opioid Requirements
timeFrame: 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.
Secondary outcomes:
measure: Patient Outcomes
timeFrame: 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.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Med Center- Trauma and Acute Care Surgery
state: California
Study officials:
affiliation: University of California, Davis
name: Ian Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: