Assessment of Peripheral Regional Anesthetic Blockade Using a Non-Invasive Surface Electromyogram (EMG) on the Affected and Unaffected Extremity
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Determine onset of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.
研究概览
简要总结
The investigators are studying a type of technology that is already used called surface electromyography (EMG). This measures and records electrical activity using sensor stickers in a non-invasive way. The purpose of this study is to use a prototype/test surface EMG machine to measure how well regional anesthesia (nerve block) is working. This device is non-invasive and being used for research use as an unapproved medical device. The information may teach us how to give nerve blocks more safely and effectively.
Study participation: Subjects having surgery will have the surface EMG sensor stickers placed on their arms or legs before surgery. These will stay on during surgery and for part of recovery.
Study visits: The study will consist of 1 visit that starts in the pre-operative area, through the surgery, and for part of recovery time after surgery.
详细描述
This study aims to investigate how non-invasive, non-significant risk EMG monitoring can be used intraoperatively to objectively characterize peripheral nerve blockade (upper or lower extremity) in pediatric, adolescent, and young adult patients undergoing surgery. We also aim to quantify the impact of sevoflurane (general anesthesia) on basal muscle tone based on EMG changes.
Hypothesis
EMG monitoring can be utilized to objectively measure neuraxial blockade, including onset, resolution, density, and dermatomal level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≤ 21 years of age
- •Patient presenting for a surgical procedure in which GA and a peripheral regional block will be used
排除标准
- •Patients > 21 years of age
- •Parent / patient refusal
- •Premature infants; neuromuscular disease; systemic infection; hemodynamic instability; coagulation disorder; degenerative CNS abnormality that precludes regional anesthesia; and local anesthetic allergy; pregnant women.
研究组 & 干预措施
General Anesthesia with peripheral regional block
All patients will have general anesthesia and a peripheral regional block (upper or lower extremity block). EMG electrodes will be placed on both the extremity to be blocked in two dermatomes within the sensory distribution of the nerve and then in the same two sensory dermatomes on the contralateral extremity that is not being blocked.
干预措施: BlockSynop surface electromyography device (Device)
General Anesthesia with peripheral regional block
All patients will have general anesthesia and a peripheral regional block (upper or lower extremity block). EMG electrodes will be placed on both the extremity to be blocked in two dermatomes within the sensory distribution of the nerve and then in the same two sensory dermatomes on the contralateral extremity that is not being blocked.
干预措施: Peripheral nerve block (Procedure)
结局指标
主要结局
Determine onset of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.
时间窗: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery- up to one day.
Performance of non-invasive surface EMG following administration of peripheral nerve blockade + general anesthesia. This will be assessed by EMG signal amplitude.
Determine resolution of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.
时间窗: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Performance of non-invasive surface EMG following administration of peripheral nerve blockade and general anesthesia. This will be assessed by EMG signal amplitude.
Determine density of peripheral nerve blockade + general anesthesia using surface EMG as measured by power of signal amplitude.
时间窗: Preoperative placement through resolution of motor blockade in the PACU. Timeframe being day of surgery - up to one day.
Performance of non-invasive surface EMG following administration of peripheral nerve block and general anesthesia. This will be assessed by EMG signal amplitude.
次要结局
- Quantify the impact of sevoflurane (%) on basal muscle tone based on EMG signal amplitudes.(Intraoperative time frame. Timeframe being day of surgery.)
研究者
Grant Heydinger
Principal Investigator - MD
Nationwide Children's Hospital