Ultrasonography Versus Palpation for Spinal Anesthesia in Obese Parturients Undergoing Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow
研究概览
简要总结
The study will compare between preprocedural ultrasonography and the conventional palpation technique for spinal anesthesia in obese parturients undergoing elective cesarean delivery
详细描述
This randomized, controlled, double-blind study will be conducted on ASA physical status II-III obese parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. The study subjects will be assigned to 2 equal groups. In the ultrasonography group, lumbar spinal ultrasonography will be performed before administration of spinal anesthesia. In the palpation group, conventional palpation of the anatomical landmarks will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status II-III parturients
- •Full term singleton pregnancy
- •Body mass index ≥ 35 Kg/m2
排除标准
- •Age < 19 years
- •Women presenting in labor
- •Contraindications to neuraxial anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection)
- •Significant spinal deformities or previous spinal surgery
- •Preeclampsia
研究组 & 干预措施
Ultrasonography
Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Lumbar Spinal Ultrasonography (Radiation)
Ultrasonography
Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Spinal Anesthesia (Procedure)
Ultrasonography
Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Intrathecal Bupivacaine (Drug)
Ultrasonography
Preprocedural lumbar spinal ultrasonography and skin marking. Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Intrathecal Fentanyl (Drug)
Palpation
Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Sham Ultrasound Procedure (Radiation)
Palpation
Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Conventional Landmark Palpation (Procedure)
Palpation
Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Spinal Anesthesia (Procedure)
Palpation
Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Intrathecal Bupivacaine (Drug)
Palpation
Sham ultrasound procedure. Conventional landmark palpation and skin marking.Spinal anesthesia will be administered with injection of intrathecal bupivacaine and intrathecal fentanyl.
干预措施: Intrathecal Fentanyl (Drug)
结局指标
主要结局
Number of Needle Passes Required to Obtain Free Cerebrospinal Fluid Flow
时间窗: Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes
Needle pass is any forward introduction of the spinal needle after its complete or incomplete withdrawal, including the first attempt.
次要结局
- Number of Participants With Paresthesia(Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes)
- Number of Participants With Failure to Obtain Free Cerebrospinal Fluid Flow(Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes)
- Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Skin Puncture(Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes)
- Rate of Successful Obtaining of Free Cerebrospinal Fluid Flow at the First Needle Pass(Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes)
- Number of Participants With Vascular Puncture(Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes)
- Number of Skin Punctures Required to Obtain Free Cerebrospinal Fluid Flow(Assessed from starting the first attempt of spinal anesthesia until successful administration of spinal anesthesia, an average of 10 minutes)
- Patient Satisfaction(Assessed at 1 minute after intrathecal injection)
- Number of Participants With Failed Spinal Block(Assessed up to 20 minutes after intrathecal injection)
- Duration of the Spinal Procedure(Assessed from enrollment in the study until completion of cesarean delivery)
研究者
Mohamed Mohamed Tawfik
Lecturer, Department of anesthesia and surgical intensive care, Primary investigator
Mansoura University