A Prospective Comparison of Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours
研究概览
简要总结
The current cornerstone of pain control for rib fractures is oral and intravenous opioids, especially in the form of patient-controlled analgesia (IV PCA), which are are associated with multiple adverse effects including sedation, respiratory depression, cough suppression, and increased risk of delirium.
In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that IVL is overall well tolerated and have shown other beneficial effects such as anti-inflammatory properties. To this date, there have been no published randomized clinical trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture pain.
Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours compared to placebo in adult patients with acute traumatic rib fractures.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures
排除标准
- •hemodynamically instability
- •mechanical ventilation
- •polytrauma (defined as bone or organ injury outside the thorax)
- •pregnancy
- •incarceration
- •local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block)
- •chronic opioid use.
研究组 & 干预措施
Placebo Comparator
Participants will receive placebo infusion consisting of normal saline
干预措施: Saline infusion (Drug)
Active Comparator
Participants will receive a lidocaine infusion
干预措施: Lidocaine infusion (Drug)
结局指标
主要结局
Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 24 Hours
时间窗: After 24 hours of treatment
MME = morphine milligram equivalent
次要结局
- Number of Pulmonary Complication Events(29 hours)
- Cumulative Oral Morphine Milligram Equivalent (OME) Consumption at 48 Hrs(After 48 hours of treatment)
- Pain Score(Baseline and 1, 10, 13, 16, and 17 hours post-lidocaine infusion)
- PIC Score(Time 0, 24 hours, 48 hour, and 72 hours.)
- Incentive Spirometry Volumes(Pre-infusion baseline and 24 hours post-infusion)
- Length of Hospital Stay(29 hours)
- Inflammatory Biomarkers(Time 0, 24 hours, and 48 hour)
研究者
Chi-Ho Ban Tsui
Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
Stanford University