Ideal Initial Bolus and Infusion Rate for Erector Spinae Plane Block Catheters
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Median Effective Dose
研究概览
简要总结
This study would like to identify the best starting dose and infusion rate for nerve blocks and nerve catheters related to the erector spinae plane block that can improve functional status and pain control on cardiac surgery patients and minimize the necessity for opioid pain control using a continuous reassessment model.
详细描述
The study will continue taking steps in helping to identify the role erector spinae plane nerve blocks have in thoracic surgery. This is a relatively new nerve block (first identified and described in 2016) and the studies that have been done and the case series that have been reported have been very promising in supporting its role in thoracic surgery. As it is a plane block (not around a specific nerve but in a general area), larger volumes and doses often have to be used in these sorts of blocks (such as a transverses abdominalis plane block) to get good spread of the local anesthetic in the plane to reach the desired nerves that pass through this plane with one injection. Our hospital has been doing these blocks for patients as a standard of care for them, but this study will take a closer look to see if there is an optimal dose and volume of medicine to improve patients' functional status and pain control to minimize the need for opioids. The study will use a continuous reassessment model to determine the optimal dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •patients undergoing planned thoracotomies and sternotomies for cardiothoracic surgery who will be taken to the cardiac surgery ICU postoperatively
排除标准
- •infection at the proposed catheter site
- •ongoing sepsis/bacteremia
- •patient unable to sit up for the procedure
- •patients requiring significant vasopressor support (>1 vasopressor)
- •patient refusal
- •less than 18 years of age (they are managed in the pediatric ICU rather than the Cardiac Surgery ICU)
研究组 & 干预措施
Bilateral catheters
patients receiving bilateral catheters (such as for patients undergoing sternotomies/midline incisions or with planned bilateral thoracotomy incisions)
干预措施: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally (Drug)
Single catheter
patients who only have one catheter in place (such as in patients who have unilateral thoracotomies and not midline sternotomies)
干预措施: Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally (Drug)
结局指标
主要结局
Median Effective Dose
时间窗: 6.5 hours
Dose at which 50% of patients achieve a clinically significant nerve block after a single bolus and after periodic programmed boluses of Ropivacaine as represented by either an adequate decrease in sensation of the chest (covering at least 5 dermatomes) or an improvement in vital capacity breaths (of 500 mL or more)
次要结局
- Blood pressure(From just before to 30 minutes after a bolus is administered)
- Change in percent oxygen saturation of hemoglobin(From just before to 30 minutes after a bolus is administered)
- Changes in electrocardiogram tracing(From just before a bolus is administered to 6.5 hours)
- Change in heart rate(From just before to 30 minutes after a bolus is administered)
- Dermatomal coverage(From just before to 30 minutes after a bolus is administered)
- Change in pain rating(From just before to 30 minutes after a bolus is administered)
- Opioid consumption(6.5 hours)
- Non-narcotic pain medication consumption(6.5 hours)