Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone in Patients With Hip or Femur Fracture: a Double Blind Randomized Clinical Trial (BupiKet)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- time to first rescue analgesia post-regional nerve blockade
研究概览
简要总结
The project is meant to evaluate the effect of a combination of medications (Bupivacaine + Ketamine) used in an ultra-sound guided nerve block for patients presenting to the Emergency Department (ED) with hip and/or femur fractures. The goal is to see whether the combination of these two medications will result in greater and longer-lasting pain relief, longer-lasting motor and sensory block and overall less need for opioid rescue analgesia.
详细描述
STUDY DESIGN
Subjects: Patients aged 18 years and older with isolated hip or femur fracture confirmed on x-ray.
DESIGN:
A randomized double-blind prospective superiority trail.
- Each patient will receive Morphine for analgesia prior to regional nerve block.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a randomized double blind study - - All the pharmacist and research manager
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Presenting with isolated hip or femur fracture confirmed on x-ray.
排除标准
- •Polytrauma
- •Unstable vitals signs
- •Allergy to Bupivacaine or Ketamine
- •Inability to give consent
- •Altered mental status
- •Greater than 100kg
- •Known end stage renal disease or hepatic dysfunction
- •Received > 2 doses of Morphine in ER prior to regional nerve block
- •Patients with failed nerve block (30 minute onset)
研究组 & 干预措施
Nerve Block with Bupivacaine an
Patients will receive an ultrasound guided regional nerve block with Bupivacaine (0.5% or 5 mg/ml) 2.5 mg/kg (max dose 175 kg) + Ketamine (50 mg/ml) 2 mg/kg. Each patient will be given a volume of 40 mL - this will be a mixture of Bupivacaine, Ketamine and 0.9% NS to make up the full 40 ml.
干预措施: Bupivacaine (Drug)
Nerve Block with Bupivacaine an
Patients will receive an ultrasound guided regional nerve block with Bupivacaine (0.5% or 5 mg/ml) 2.5 mg/kg (max dose 175 kg) + Ketamine (50 mg/ml) 2 mg/kg. Each patient will be given a volume of 40 mL - this will be a mixture of Bupivacaine, Ketamine and 0.9% NS to make up the full 40 ml.
干预措施: Ketamine (Drug)
Nerve Block with Bupivacaine al
Patients will receive an ultrasound guided regional nerve block with Bupivacaine 0.5% only. Each patient will be given a volume of 40 ml - this will be a mixture of Bupivacaine and 0.9% NS to make up the full volume of 40 mL
干预措施: Bupivacaine (Drug)
结局指标
主要结局
time to first rescue analgesia post-regional nerve blockade
时间窗: 0-24 hours
The difference in time from administration of pain medication to rescue analgesia
次要结局
- Pain score at 30 minutes(30 minutes)
研究者
Antonios Likourezos
Research Manager; Co-Investigator
Maimonides Medical Center