NCT02767076Unknown不适用
Paramedian Spinal Anaesthesia for Orthopaedic Knee Surgery: Comparison Between Conventional Blind Land-mark Guided Technique and Real-time Ultrasound Guided Technique: a Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of puncture attempts
研究概览
简要总结
To identify the value of using the ultrasound in applying a commonly used regional anaesthetic procedure (spinal anaesthesia) when compared with the conventional landmark guided approach, regarding the efficiency of the anaesthetic technique, incidence of associated common complications and patient's satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA physical status I-II patients
- •Patient's consented approval
- •Males or Females
- •Aged 18-60 years old
- •Body mass index less than 30
- •Scheduled for orthopaedic knee surgeries
排除标准
- •Age less than 18, and more than 60 years
- •Body mass index more than 30
- •Patient refusal or failure to obtain consent
- •Patient in whom spinal anaesthesia is contraindicated (infection at the site of needle insertion, coagulopathy reflected by values of INR≥ 1.2 or platelets count≤ 75.000, or receiving oral anticoagulants)
- •Known sensitivity to local anaesthetics
- •Pre-existing neurological disorder or neuromuscular disease
- •Clinically obvious or known spinal deformity or previous spinal surgery
研究组 & 干预措施
Conventional
Active Comparator
conventional paramedian spinal anesthesia
干预措施: conventional paramedian spinal anesthesia (Procedure)
Ultrasound
Experimental
ultrasound guided paramedian spinal anesthesia
干预措施: ultrasound guided paramedian spinal anesthesia (Device)
结局指标
主要结局
Number of puncture attempts
时间窗: during the time taken for introducing the regional anesthetic technique in the intraoperative period
次要结局
- The visibility of the ligamentum flavum-dura mater complex by the US.(during the time taken for introducing the regional anesthetic technique in the intraoperative period)
- Patient's satisfaction score regarding the anaesthetic technique(within 2 hours in the postoperative period)
- Landmark palpation easiness score(during the time taken for introducing the regional anesthetic technique in the intraoperative period)
- Duration of the anaesthetic procedure(during the time taken for introducing the regional anesthetic technique in the intraoperative period)
- The incidence of failure of introducing spinal anaesthesia using each of the study techniques.(during the time taken for introducing the regional anesthetic technique in the intraoperative period)
- Post dural puncture headache (incidence-onset-duration-severity)(within 3 days after the operation)
- The incidence of paraesthesia and backache(during the time taken for introducing the regional anesthetic technique in the intraoperative period)
研究者
Sohib Mohamed Galal Abdelfatah
anesthesia specialist
Cairo University
研究点 (1)
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