Is Jedi Grip Efficient And Effective In Ultrasound Guided Peripheral Nerve Block: A Prospective, Randomized, Observer-Blinded Comparison Between Single And Double Operator Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- success rate
研究概览
简要总结
In this prospective randomized controlled observer-blinded study we aimed to compare the efficacy of a single operator technique so called Jedi Grip and conventional technique requiring double operator in ultrasound guided axillary brachial plexus block.
详细描述
Patients aged between 18 and 65 years, American Society of Anesthesiologists (ASA) physical status I to II ) undergoing elective hand, wrist and forearm surgery were prospectively enrolled. Patients were randomly assigned to Group C (conventional technique) or group J (Jedi technique). In both groups, axillary plexus blockage was provided by applying 5cc of a mixture of 10 cc 0.5% bupivacaine and 10 cc 2% prilocaine to the ulnar, radial, median and musculocutaneous nerves. Parameters such as performance time and the number of needle passes were recorded during procedure. Subsequently, a blinded observer evaluated and recorded parameters related to the success of blockage. The main outcome variable was performance time and success rate (surgical anesthesia).
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)
盲法说明
After completion of the block, a blinded observer recorded demographic data and questioned the patients for felt pain related to the block procedure using a 10-cm visual analog scale (0 cm = no pain, 10 cm = worst imaginable pain). Patients were also questioned for symptoms related to the local anesthetic toxicity.
Subsequently, measurements of brachial plexus blockade were carried out every 5 mins until 30 mins by the same blinded observer.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing elective hand, wrist and forearm surgery
排除标准
- •hepatic or renal failure, serious cardiac or pulmoner disease, local or systemic infection, sepsis, coagulation disorder, neurological, muscular or psychiatric disease, body mass index (BMI) below 18.5 or above 35, drug and substance abuse, pregnancy, refusal of regional anesthesia, history of allergy to local anesthetics, mental-motor retardation (inability to consent or assess the visual analog scale(VAS) pain score), preoperative long-term NSAIDs or opioid use and prior surgery in the axillary regions.
结局指标
主要结局
success rate
时间窗: during operation
patients percentage with provided successful anesthesia
block performance time
时间窗: during procedure
the sum of imaging and needling times
次要结局
- Onset time of sensory block(before operation)
- Onset time of motor block(before operation)
研究者
ismail aytaç
Principal Investigator
Ankara City Hospital Bilkent