Pharmacokinetic Profile and Dermatomal Coverage of the Erector Spinae Plane Block: a Comparison of Bolus Dosing and Continuous Infusion
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The goals of this study are as follows:
- to confirm the safe dosing of ropivacaine for the erector spinae plane block
- develop a pharmacokinetic profile of the erector spinae plane block, which will help demonstrate how quickly and how closely toxic levels are reached when a routine dose of ropivacaine is given for this nerve block
- assess numbness created by the erector spinae block when routine doses are administered
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Participant's age is greater than 18 years
- •Participant is undergoing a primary coronary artery bypass grafting surgery or heart valve replacement that requires a midline sternotomy incision
- •Participant's surgery is being performed by Dr. Vig Kasirajan
排除标准
- •Diagnosis of cirrhosis, hepatitis, primary sclerosing cholangitis
- •Abnormal liver function tests demonstrated by lab results
- •Allergy to lidocaine, ropivacaine, or midazolam
- •Morbid obesity, defined as body mass index greater than 40
- •Existing skin neuropathy on the chest or back
- •Body weight less than 50 kg
- •Participant is not able to provide verbal feedback, such as when the participant develops altered mental status or requires prolonged mechanical ventilation and sedation
- •Participant remains intubated on post-operative day 1
- •Pregnant women
研究组 & 干预措施
single
local anesthetic is delivered as a single bolus
干预措施: Ropivacaine 0.25%-NaCl 0.9% Injectable Solution (Drug)
continuous
local anesthetic is delivered as a continuous infusion
干预措施: Ropivacaine 0.2%-NaCl 0.9% Injectable Solution (Drug)
结局指标
主要结局
Cmax
时间窗: 28 hours
The maximum concentration of serum ropivacaine after pre-determined dose is delivered through the ESP nerve catheter
Area of analgesia
时间窗: 4 hours
The area of numbness experienced in the chest wall; measured using a pinprick test and documented on a cartoon map showing a chest wall and dermatomal borders
Duration of analgesia
时间窗: 4 hours
The duration of numbness to the chest wall; start time will be when the local anesthetic bolus is given, and end time will be when the participant reports the resolution of chest wall numbness
Tmax
时间窗: 28 hours
The time elapsed from initial ropivacaine administration to Cmax
次要结局
未报告次要终点