Computer Assisted Instrument Guidance (CAIG) For Orthopedic Peripheral Nerve Blocks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
研究概览
简要总结
The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.
详细描述
This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Undergoing orthopedic surgery who are candidates for peripheral nerve blocks for control of postoperative pain
- •Able to give written informed consent
排除标准
- •Unable to give informed consent
- •Patients in whom regional anesthesia is contradicted
结局指标
主要结局
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
时间窗: Immediately after intervention (within 2 hours)
次要结局
- Clinician Rating of the Device(Immediately following intervention (within 2 hours))
- Number of Times Needle Needs Repositioning(Immediately following intervention (within 2 hours))
- Number of Patients That Needed Rescue Opioids(During hospital stay (maximum 3 days))
- Number of Attempts(Immediately following intervention (within 2 hours))
- Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire(Post-op day 1)
- Incidence of Postoperative Nausea and Vomiting(During hospital stay (maximum 3 days))
- Undesired Muscle Weakness Measured Subjectively(During hospital stay (maximum 3 days))