Intercostal Liposomal Bupivacaine for the Management of Blunt Chest Wall Trauma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Opioid Requirement at 48 Hours Post-randomization.
研究概览
简要总结
This is a study of liposomal bupivacaine for pain control in patients with blunt chest wall trauma.
详细描述
The purpose of this study is to evaluate the efficacy of liposomal bupivacaine to provide analgesia via paravertebral intercostal nerve block following significant blunt chest trauma, minimizing adverse outcomes, length of stay and overall narcotic use. The primary outcome of the study is to compare requirements between the bupivacaine group and a standard-of-care group.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anticipated length of stay of at least 72 hours
- •Blunt chest wall trauma with two or more rib or sternal fractures
- •Demonstrated ability to achieve > 50% predicted inspiratory capacity based on ideal body weight using IS within the first 24 hours of admission
排除标准
- •Known allergy to bupivacaine
- •Respiratory failure requiring intubation within 24 hours prior to enrollment
- •Known or suspected atrioventricular nodal blockade process requiring cardiology evaluation or pacemaker placement
- •Hemodynamic instability (defined as new intravenous vasopressor or inotrope requirement or mean arterial pressure < 55 mmHg)
- •Signs of active myocardial ischemia or non-ST elevation MI
- •> 20 rib fractures
- •Weight < 50 kg or > 150 kg
- •Pregnancy
- •Incarceration
研究组 & 干预措施
Liposomal bupivacaine
1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
干预措施: Liposomal bupivacaine (Drug)
0.9% sodium chloride
1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
Opioid Requirement at 48 Hours Post-randomization.
时间窗: 48 hours following randomization.
Opioid requirement (in morphine equivalents) at 48 hours post-randomization
Opioid Requirement at 72 Hours Post-randomization
时间窗: 72 hours following randomization.
Opioid requirement (in morphine equivalents) at 72 hours post-randomization
Opioid Requirement at 96 Hours Post-randomization
时间窗: 96 hours following randomization.
Opioid requirement (in morphine equivalents) at 96 hours post-randomization
Opioid Requirement at 24 Hours Post-randomization
时间窗: 24 hours following randomization.
Opioid requirement (in morphine equivalents) at 24 hours post-randomization
次要结局
- Development of Pneumonia(96 hours following randomization)
- Self-reported Pain at 96 Hours Post-randomization(At 96 hours post-randomization)
研究者
Michael Goodman
instructor
University of Cincinnati