Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial
Overview
- Phase
- Phase 2
- Intervention
- Liposomal Bupivacaine
- Conditions
- Femoral Fractures
- Sponsor
- Ian Elliott Brown
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Opioid Requirements
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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
Investigators
Ian Elliott Brown
Assistant Professor of Surgery
University of California, Davis
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •\>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
- •Coagulopathy with INR \>1.5
- •Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)
Arms & Interventions
Liposomal Bupivacaine
In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered
Intervention: Liposomal Bupivacaine
Ropivacaine HCL
In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered
Intervention: Ropivacaine HCL
Outcomes
Primary Outcomes
Opioid Requirements
Time Frame: 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.
Total opioid requirements during the 96 hour randomization period measured in milligram morphine equivalents
Secondary Outcomes
- Patient Outcomes(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.)