Effects of Liposomal Bupivacaine for Acute Pain in Hip and Femur Fractures: a Randomized, Active Comparator-controlled, Blinded Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Opioid Requirements
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •>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)
- •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
研究组 & 干预措施
Liposomal Bupivacaine
In patients with femur or hip fractures, a fascia iliaca compartment block using liposomal bupivacaine will be administered
干预措施: Liposomal Bupivacaine (Drug)
Ropivacaine HCL
In patients with femur or hip fractures, a fascia iliaca block using using 0.2% ropivacaine will be administered
干预措施: Ropivacaine HCL (Drug)
结局指标
主要结局
Opioid Requirements
时间窗: 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
次要结局
- 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.)
研究者
Ian Elliott Brown
Assistant Professor of Surgery
University of California, Davis