跳至主要内容
临床试验/NCT07269184
NCT07269184尚未招募不适用

Impact of Ultrasound Guidance on Central Neuraxial Block Success in Patients With Non-Palpable Vertebral Anatomy

Sakarya University0 个研究点目标入组 60 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
主要终点
first-attempt success rate

研究概览

简要总结

Patients scheduled to undergo general surgery with planned epidural catheter placement will be evaluated by comparing two different techniques routinely used in anesthesia practice for catheter insertion.

A total of 60 patients aged 18-60 years, classified as ASA I-III, and scheduled to undergo general surgical procedures with epidural catheter placement at Sakarya University Faculty of Medicine Training and Research Hospital will be included in the study. All patients will be classified according to the following palpation scoring system to assess the difficulty of vertebral palpation:

Palpation Score: All patients will be evaluated in the sitting position, and the difficulty of palpating vertebral landmarks will be scored between 0 and 3:

0: Spinous processes and interspinous spaces are clearly identifiable

  1. Spinous processes are palpable, but interspinous spaces are not clearly identifiable
  2. Spinous processes are not palpable, interspinous spaces are not identifiable, but the vertebral column can be palpated either on or off the midline
  3. Spinous processes and interspinous spaces are not palpable, and vertebral structures are not clearly distinguishable Patients with a palpation score of 3 will be included in the study group. Patients with a score of 0 will be included as the control group.

Patients will be divided into two groups: Anatomical Landmark Group and Ultrasound Group.

In the Ultrasound Group, surface marking will be performed in the operating room using ultrasonography.

In the Anatomical Landmark Group, after the patient is positioned sitting in the operating room, the insertion site will be estimated by palpation of anatomical landmarks.

After determining the needle entry point in both groups, epidural catheterization will be performed under sterile conditions according to our routine practice. The two groups will be compared in terms of first-attempt success rate, total procedure time, number of needle redirections, and complications occurring during the procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for elective general surgery
  • Planned epidural catheterization
  • Aged 18-60 years
  • ASA physical status I-III
  • Spinous processes not palpable (class3)

排除标准

  • Contraindication to epidural catheterization
  • ASA physical status IV-V
  • Diagnosed with scoliosis
  • Presence of anatomical deformities
  • Declining to participate in the study
  • Patients for whom follow-up conditions cannot be ensured

结局指标

主要结局

first-attempt success rate

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

BURCUCAN

Asist. Doctor

Sakarya University

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