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临床试验/NCT05240846
NCT05240846招募中不适用

Paramedian Approach for Spinal Anesthesia Using Ultrasound Assistance Versus Conventional Palpation in Morbidly Obese Patients: A Randomized Controlled Trial

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
64
试验地点
1
主要终点
The rate of successful dural puncture on the first attempt

研究概览

简要总结

The aim of this study is to compare the paramedian approach for spinal anesthesia using ultrasound assistance (USAS) versus conventional palpation in morbidly obese patients undergoing elective surgeries.

详细描述

Performing spinal anesthesia using a conventional approach can be considerably challenging in obese patients. Multiple needle attempts may lead to a higher incidence of complications (e.g., postdural puncture headache, paresthesia, hematoma, and infection) and increase patient discomfort and dissatisfaction. Therefore, novel techniques are needed to improve the success rate of spinal anesthesia for such patients.

There are two puncture approaches for spinal anesthesia: median approach puncture and paramedian approach puncture. Early studies have noted that the success rate of paramedian approach puncture was higher than that of median approach puncture and that it is associated with fewer complications and postoperative complications.

A paramedian approach has been shown to improve the success rate of spinal anesthesia, especially in patients who are unable to sit up or those with a degenerative spine condition. The use of ultrasound has been suggested to increase the efficacy of spinal anesthesia.

Recently, ultrasound has emerged as a way to facilitate lumbar neuraxial blocks, namely, the ultrasound assistance (USAS) technique. The ultrasound assistance technique is beneficial for lumbar neuraxial anesthesia, improving technique performance by providing reliable anatomical information.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Both sexes
  • Body mass index (BMI) ≥ 40 kg/m2
  • Patients undergoing elective surgeries

排除标准

  • Rejection of spinal anesthesia
  • History of spinal deformity or spinal surgery
  • Contraindications to spinal anesthesia (infection of the puncture site, coagulation dysfunction, allergy to local anesthesia, insufficient blood volume or abnormal spinal anatomy).

结局指标

主要结局

The rate of successful dural puncture on the first attempt

时间窗: Intraoperatively

First-attempt success rate will be recorded

次要结局

  • Patients' satisfaction after surgery(24 hours Postoperative)
  • Complications after anesthesia(24 hours Postoperative)
  • Total success rate of spinal anesthesia(Intraoperatively)
  • Adverse reactions during puncture(Intraoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Fouad Algyar

Doctor

Kafrelsheikh University

研究点 (1)

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