Reliability of Real-time Ultrasound Guidance as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percentage of successful epidural blocks after US-guided insertion of epidural catheters
研究概览
简要总结
Various modalities have been proposed for real-time confirmation of loss of resistance (LOR) for thoracic epidural blocks. With real-time ultrasound (US) guidance, the anesthesiologist attempts to visualize the sonographic advancement of the epidural needle and penetration of the epidural space (as detected by LOR)
This observational study is set out to confirm the reliability of real-time ultrasound guidance as an adjunct to LOR for thoracic epidural blocks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •American Society of Anesthesiologists classification 1-3
- •Body mass index between 20 and 35 (kg/m2)
排除标准
- •Adults who are unable to give their own consent
- •Sepsis (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. leukocytosis, increased c-reactive protein, increased procalcitonin)
- •Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
- •Allergy to local anesthetics (LAs)
- •Prior surgery in the thoracic spine
结局指标
主要结局
Percentage of successful epidural blocks after US-guided insertion of epidural catheters
时间窗: 15 minutes after the local anesthetic injection through the epidural catheter
After fifteen minutes of local anesthetic administration (4- mL dose of lidocaine 2% with epinephrine 5 μg/mL ), an investigator will apply ice to the T1 to L4 dermatomes bilaterally. The criterion standard for success will be the presence of an epidural block, defined as a block to ice in at least 2 dermatomes bilaterally. If operators could not advance the catheter past the needle tip after 2 attempts despite a 180-degree rotation of the bevel between the first and second attempts, epidural blocks will be considered failures.
次要结局
- Localization of blocked dermatomes(15 minutes after the local anesthetic injection through the epidural catheter)
- Image time(Up to 30 minutes after skin disinfection)
- Catheter installation time(Up to 30 minutes after skin disinfection)
- Needle time(Up to 30 minutes after skin disinfection)
- Number of blocked dermatomes(15 minutes after the local anesthetic injection through the epidural catheter)
- Block performance time(Up to 30 minutes after skin disinfection)
- Epidural block-related complications(Up to 30 minutes after skin disinfection)
研究者
Julian Aliste
Assistant Professor
University of Chile