Conventional Palpation Versus Ultrasound Assisted Spinal Anesthesia in Obstetrics: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- First pass success rate
研究概览
简要总结
Spinal anesthesia in obese parturients is commonly difficult yet there are no guidelines to direct best practice. The failure leads to suboptimal patient outcomes.
Ultrasonography is now considered standard care for central venous access and regional anesthesia and it can be used to visualize the anatomy of the spine for this procedure.
Goal of the study
Evaluate the benefits of preprocedural ultrasound scanning to facilitate neuraxial anesthesia and improve the first-attempt success rate in obese parturients.
详细描述
This was a prospective, randomized controlled trial conducted between Nov 2022 and December 2022 in the gynecological operating room of Mongi Slim hospital.
Ethical approval was provided by our Institutional Hospital Ethics Committee.
Written informed consent was obtained from all the participants.
Study population
- Inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Fictional ultrasound identification Screen device shut down Intervertebral space identified using the standard palpation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >18 years old
- •Normal singleton pregnancy
- •Gestational age ≥ 37 weeks
- •BMI ≥ 30 Kg/ m2 (weight measured on the day before delivery)
- •Planned cesarean section
排除标准
- •Spinal anesthesia failure
- •Poorly Tolerated spinal anesthesia
研究组 & 干预措施
standard group
Fictional ultrasound identification Screen device shut down Intervertebral space identified using the standard palpation
干预措施: fictional preprocedure spinal ultrasound (Procedure)
ultrasound group
pre-puncture ultrasound-guided neuraxial anesthesia group
干预措施: Preprocedural spinal ultrasound (Procedure)
结局指标
主要结局
First pass success rate
时间窗: before spinal anesthesia
First pass success rate without needle redirection or reinsertion
次要结局
- Requirement of needle redirection(before spinal anesthesia)
- Procedure Time(before spinal anesthesia)
- Patient satisfaction score(before spinal anesthesia)
- Number of puncture attempts(before spinal anesthesia)
- Number of intervertebral interspaces attempted(before spinal anesthesia)
- Possible complications(before spinal anesthesia)
研究者
Mhamed Sami Mebazaa
Conventional palpation versus ultrasound assisted spinal anesthesia in obstetrics: A randomized controlled trial
Mongi Slim Hospital