Ultrasound Visualization v. Electrical Nerve Stimulation for the Safety and Effectiveness of Interscalene/Axillary Nerve Block in Upper Extremity Surgery: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Incidence of Successful Block: defined by avoidance of General Anesthesia (which will be documented in the medical record as such)
研究概览
简要总结
Hypothesis and Specific Aims:
The investigators hypothesize that ultrasound (US) visualization is as effective as nerve stimulation (NS) for identification of peripheral nervous structures and may be associated with less trauma and patient discomfort. Specifically, the investigators believe that equivalent rates of surgical anesthesia are achievable with non-invasive ultrasonic needle guidance in comparison to needle guidance by intensity of motor fiber response to intermittent electrical nerve stimulation. Specifically, the number of needle sticks to identify the brachial plexus and total time to plexus sheath injection may be reduced while achieving similar efficacy rates. The investigators hypothesize that similar composite safety and efficacy endpoints but improved patient satisfaction and acceptance will favor US over NS guidance of nerve blocks indicated for surgery on the extremity surgery. However, the investigators believe that an economic assessment based upon capital hardware investment, operating room utilization, total block time, and pay for performance patient satisfaction metrics require examination prior to assimilation of new technology into clinical practice.
详细描述
This is a prospective randomized study of 450 consecutive patients presenting for upper extremity surgery scheduled to receive NB without general anesthesia for their surgical procedure. Patients will be randomized to receive one of two nerve localization techniques in a 1:1 randomization ratio. Primary intraoperative providers of supplemental sedative, additional local anesthetic infiltration or analgesia, general anesthesia and assessors of VAS or PCI will be blinded to the technique.
Patients over 18 years of age presenting for elective upper extremity surgery planned in the supine position under isolated interscalene or axillary nerve block will be screened. Up to 450 patients undergoing unilateral upper extremity procedures at Lehigh Valley Hospital will be enrolled.
STUDY PROCEDURES Screening:
All patients meeting inclusion criteria and not meeting exclusion criteria will be eligible to be enrolled. All subjects who have preadmission testing will be recruited prior to their surgical procedure with initial contact made before the day of their scheduled surgery. For patients who do not have preadmission testing scheduled and are found to be eligible for the study on the day of surgery, those patients will be consented for the study the morning of their procedure by the study anesthesiologist. Only patients who are able to understand English and who are able to legally give written informed consent will be recruited to the study. Following signed informed consent (IRB approved) and permission of their surgeon and anesthesiologist and prior to the start of anesthesia, vital signs, standard lab tests, patient history and physical examination will be reviewed.
Day of Procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Male or female patients older than 18 years of age at the time of screening
- •ASA Class I - IV, undergoing unilateral elective surgical procedure involving the shoulder, arm, elbow, forearm, or hand
- •Planned interscalene block
排除标准
- •Peripheral neuropathy
- •Coagulopathy
- •Anticoagulant treatment that would preclude regional anesthesia
- •Local anesthetic allergy
- •Infection at the site of injection
结局指标
主要结局
Incidence of Successful Block: defined by avoidance of General Anesthesia (which will be documented in the medical record as such)
时间窗: 30 minutes after injection
次要结局
- Amount of sedation required for block. (mg of drug)(30 minutes after injection)
研究者
Nanette Schwann, M.D.
MD
Allentown Anesthesia Associates