A Single-Center, First-in-Human, Randomized, Controlled, Feasibility Study of a New Device for the Real-Time Continuous Monitoring of the Injection Pressure of Local Anesthetic in Subjects Undergoing Ultrasound-guided Peripheral Nerve Block: the Smart Needle Monitoring System Investigation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group
研究概览
简要总结
The goal of this clinical trial with medical device is to learn if the Smart Needle Monitoring System works to maintain a safe low injection pressure during a type of regional anaesthetic (Peripheral Nerve Block (PNB)) in patients due to undergo surgery below the elbow . It will also learn about the safety of the device and patients' perception of the quality of anesthesia.
Participants will:
- be operated locally according to standard clinical practice
- undergo post-anesthesia recovery and any neurologic symptoms or signs assessment on postoperative days 1 and 7
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Informed Consent signed by the subject
- •Age ≥ 18 years
- •Scheduled for elective surgery below the elbow (e.g., hand surgery, distal radius surgery, forearm surgery) requiring an axillary block
- •ASA physical status I-III
- •Ability to understand the investigation
- •Ability and willingness to follow and complete the procedures of the investigation
排除标准
- •Contraindications to the axillary block (e.g., local infection)
- •Refusal of locoregional anesthesia for the surgical procedure
- •Pre-existing neurologic deficits in the operative extremity
- •Body Mass Index ≥ 35 kg/m2
- •Known allergy to local anesthetic (mepicavaine hydrochloride)
- •Inability to comply with post-operative evaluations e.g. due to language problems, psychological disorders, dementia, etc. of the subject
研究组 & 干预措施
Smart Needle displaying
The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will display real-time and record the injection pressure profile during the entire PNB procedure.
The anesthesiologist will use the real-time visual feedback to maintain a low injection pressure profile (i.e., not higher than 15 psi) and avoid pressure peaks. The anesthesiologist can immediately stop the injection if there is a sudden increase in pressure, reposition the needle and start again, while always maintaining a low injection pressure profile
干预措施: Smart Needle Monitoring System (Device)
Smart Needle flipped
The Smart Needle Monitoring System is used to perform the ultrasound-guided axillary block. The monitor connected to the Smart Needle will be flipped allowing the recording of the injection pressure but not the real-time visualization by the anesthesiologist, who will perform the procedure as usual without a pressure visual feedback
干预措施: Smart Needle Monitoring System (Device)
结局指标
主要结局
proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group
时间窗: Perioperative
The proportion of injected nerves with at least one injection pressure peak in the investigational group compared to the standard (control) group. A peak is defined as an injection pressure reaching a value above the threshold of 15 psi
次要结局
- Success of the block(Perioperative)
- Number of times of needle tip repositioning(Perioperative)
- Quality of anesthesia from a patient's perspective(postoperative, 1 and 7 days after intervention)
- Total number of injection pressure peaks(Perioperative)
研究者
Dossi Roberto
MD
Ente Ospedaliero Cantonale, Bellinzona