跳至主要内容
临床试验/NCT07549776
NCT07549776已完成不适用

Ultrasound-guided Versus Landmark-based Spinal Anesthesia in Obese Parturients Undergoing Cesarean Section: a Prospective Comparative Study

Instituto Nacional Materno Perinatal, Peru1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月1日最近更新:
适应症
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
100
试验地点
1
主要终点
First-attempt success rate of spinal anesthesia

研究概览

简要总结

Spinal anesthesia is the most commonly used anesthetic technique for cesarean section. However, in obese parturients, identification of the optimal puncture site using anatomical landmark palpation can be challenging because of altered anatomy. Preprocedural ultrasound has been proposed as a tool to improve localization of the puncture site and facilitate neuraxial access.

This is a prospective comparative study included 100 obese parturients undergoing cesarean section under spinal anesthesia. Participants were allocated to one of two comparison groups according to the puncture site localization technique: a preprocedural ultrasound group and an anatomical landmark palpation group.

The primary outcome is the first-attempt success rate, defined as successful cerebrospinal fluid return after the first needle insertion without needle redirection or a new skin puncture. Secondary outcomes include the number of puncture attempts, needle redirections, need for rescue interventions, incidence of paresthesia and vascular puncture during the procedure, and procedural times.

详细描述

This prospective comparative study aims to evaluate the effectiveness of preprocedural ultrasound-guided marking compared with the conventional anatomical landmark palpation technique for spinal anesthesia in obese parturients undergoing cesarean section.

A total of 100 parturients with a body mass index (BMI) ≥ 30 kg/m² were prospectively allocated to one of two comparison groups according to the puncture site localization technique. In the ultrasound group, the puncture site was identified using preprocedural ultrasound to determine the optimal intervertebral space and needle insertion trajectory. In the landmark group, the puncture site was identified using conventional anatomical landmark palpation.

The primary outcome was the first-attempt success rate, defined as successful cerebrospinal fluid return after the first needle insertion without needle redirection or an additional skin puncture. Secondary outcomes included the number of puncture attempts, needle redirections, need for rescue interventions, incidence of paresthesia and vascular puncture during needle insertion, and procedural times (site identification time, puncture time, and total procedure time).

This study evaluated whether preprocedural ultrasound-guided marking improves the technical performance of spinal anesthesia compared with conventional anatomical landmark palpation in obese parturients undergoing cesarean section.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Due to the nature of the intervention, blinding of the operators was not feasible.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Pregnant women undergoing cesarean section
  • Body mass index (BMI) ≥ 30 kg/m² at the time of cesarean section
  • Scheduled for cesarean section under spinal anesthesia

排除标准

  • Congenital spinal deformities
  • History of spinal surgery
  • Coagulopathy
  • Infection at the puncture site
  • Allergy to local anesthetics
  • Emergency cesarean section (NICE category 1)

研究组 & 干预措施

Ultrasound-guided group

Active Comparator

Preprocedural ultrasound was used to identify and mark the optimal puncture site in obese parturients undergoing cesarean section (n = 50).

干预措施: Ultrasound-guided preprocedural marking (Procedure)

Landmark-based group

Active Comparator

The puncture site was identified using anatomical landmark palpation in obese parturients undergoing cesarean section (n = 50)

干预措施: Landmark-based palpation (Procedure)

结局指标

主要结局

First-attempt success rate of spinal anesthesia

时间窗: During the spinal anesthesia procedure

Successful cerebrospinal fluid return after the first needle insertion without redirection.

次要结局

  • Number of puncture attempts(During the spinal anesthesia procedure)
  • Number of needle redirections(During the spinal anesthesia procedure)
  • Need for rescue intervention(During the spinal anesthesia procedure)
  • Incidence of paresthesia(During the spinal anesthesia procedure)
  • Incidence of vascular puncture(During the spinal anesthesia procedure)
  • Total procedure time(During the spinal anesthesia procedure)
  • Puncture time(During the spinal anesthesia procedure)

研究者

发起方
Instituto Nacional Materno Perinatal, Peru
申办方类型
Other
责任方
Principal Investigator
主要研究者

EDDISSON REYNALDO QUISPE PILCO

Staff Anesthesiologist, Department of Anesthesia

Instituto Nacional Materno Perinatal, Peru

研究点 (1)

Loading locations...

相似试验