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临床试验/NCT07327801
NCT07327801已完成不适用

Impact of Ultrasound Guidance on the Performance of Spinal Anesthesia

Military Hospital of Tunis1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
136
试验地点
1
主要终点
procedure time

研究概览

简要总结

Neuraxial anesthesia is a commonly employed technique for subumbilical surgical procedures due to its effectiveness and safety profile. The advent of ultrasound technology has introduced the possibility of visualizing anatomical landmarks in real time, thereby facilitating more accurate and potentially safer subarachnoid punctures. This study aims to compare conventional spinal anesthesia, based on palpation, with ultrasound-guided spinal anesthesia, focusing on procedural ease and overall facilitation.

it's a prospective, single-center, randomized, single-blind study. We included patients aged 18 years or older, classified as ASA I or II, scheduled for elective surgery, and who provided written informed consent. Exclusion criteria included failed subarachnoid puncture, conversion to general anesthesia, or the occurrence of major intraoperative complications such as vasovagal episodes or cardiac rhythm disturbances. Participants were randomly assigned, based on a randomization table, into two groups: Group1 (traditional technique), in which spinal anesthesia was performed using the conventional palpation-based method for space localization; and Group2 (ultrasound-guided technique), in which spinal anesthesia was performed under real-time ultrasound guidance. The primary outcome was the total procedure time, measured in seconds from the end of skin antisepsis to the initiation of subarachnoid injection. Secondary outcomes included the number of puncture attempts, the number of needle redirections within the same interspace, the occurrence of procedural incidents, and postoperative complaints such as radicular pain, osseous contact pain, intraoperative paresthesias, and traumatic punctures.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years or older.
  • Classified as American Society of Anesthesiologists (ASA) physical status I or II.
  • Scheduled for elective surgery under spinal anesthesia.
  • Provided written informed consent.

排除标准

  • Failed subarachnoid puncture.
  • Conversion to general anesthesia.
  • Occurrence of major intraoperative complications (e.g., vasovagal episodes, cardiac rhythm disturbances).

研究组 & 干预措施

Conventional spinal anesthesia

Active Comparator

The operator began by palpating the posterior superior iliac spines to mentally determine the Tuffier's line, which roughly corresponds to the L4-L5 intervertebral space. The spinous processes were then palpated to precisely locate the targeted intervertebral space. The needle was subsequently inserted until cerebrospinal fluid return was obtained, and the anesthetic agent was administered slowly

干预措施: Conventional spinal anesthesia (Device)

Ultrasound-guided spinal anesthesia

Active Comparator

The operator set up the sterile equipment, which included an ultrasound machine equipped with a low-frequency convex probe (2-5 MHz). The probe, previously disinfected, was covered with a sterile sheath containing sterile coupling gel.

First, the transducer was positioned in a paramedian sagittal plane, placed 1-2 cm lateral to the spinous processes. The sacrum was identified as a flat, hyperechoic structure producing a marked acoustic shadow, serving as the starting landmark for identifying successive lumbar intervertebral spaces. By gradually sliding the transducer cephalad, the vertebral laminae appeared as hyperechoic lines alternating with their posterior acoustic shadows. The interlaminar spaces, located between two adjacent laminae, form true acoustic windows that allow visualization of the underlying neuraxial structures.

The exploration continued until the intervertebral space deemed optimal for puncture was identified. The probe was then switched to a midline posit

干预措施: Ultrasound-guided spinal anesthesia (Device)

结局指标

主要结局

procedure time

时间窗: 60sec

次要结局

未报告次要终点

研究者

发起方
Military Hospital of Tunis
申办方类型
Other
责任方
Principal Investigator
主要研究者

askrihaythem

Associate Professor

Military Hospital of Tunis

研究点 (1)

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