Ultrasound Pre-procedural Scan vs Conventional Landmark-guided Technique in Spinal Anesthesia in Orthopedic Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Needle redirections
研究概览
简要总结
The study is aimed at evaluating whether ultrasound pre-procedural scan with Accuro may reduce needle redirections when performing spinal injection in patients with BMI = or > 30 in orthopedic surgery
详细描述
This is a open-label randomised controlled study.
90 patients will be recruited and divided into two groups of 45 patients per group.
Patient recruitment will be performed by patient visit and checking inclusions and exclusion criteria. After written informed consent, every single patient will be allocated in one of the two groups following a computer generated randomization list.
Patients in both groups will undergo:
- standard monitoring with Non Invasive Blood Pressure (NIBP) cuff, three-lead electrocardiography (ECG) and Pulse-oximetry (SpO2).
- Peripheral intravenous access
- Sedation (as prescribed by the OR anesthesiologist)
- Spinal anesthesia performed by anesthesiologists skilled in both techniques (conventional landmark technique or Accuro guided) at the L3-L4, L4-L5 or L5-S1 level, with a 25 or 27 Gauge needle, with the surgical side declive or proclive according to the baricity of the local anesthetic used (sitting position, when needed, will be reported in the CRF)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •BMI ≥ 30 kg/m2
- •American Society of Anesthesiologists' (ASA) classification I-III
- •Orthopedic surgery to be performed under spinal anesthesia
- •Able to understand and to sign informed consent
排除标准
- •Local anaesthetic allergy
- •Serious spine deformities
- •Previous spine surgery
- •Inability to express informed consent
- •Contraindications to spinal anaesthesia
- •Pregnancy
研究组 & 干预措施
Conventional landmark-guided technique
In this arm spinal anesthesia will be performed by using conventional cutaneous landmarks
干预措施: cutaneous landmarks (Procedure)
Accuro device guided technique
In this arm spinal anesthesia will be performed only after having detected the intralaminar space, the mid-line, the depth and the orientation for spinal needle insertion with pre-procedural scan performed with Accuro device
干预措施: Accuro (Device)
结局指标
主要结局
Needle redirections
时间窗: duration of spinal injection procedure
To evaluate if there is a significant difference about numbers of needle redirections between conventional landmark guided technique and Accuro device guided technique
次要结局
- Number of needle insertions(duration of spinal injection procedure)
- Procedure duration(duration of spinal injection procedure)
- Procedure failure(duration of surgical procedure)
- Side effects and complications(36 months)
- Patient satisfaction(24 hours)
研究者
Daniela Ghisi
principal investigator
Istituto Ortopedico Rizzoli