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临床试验/NCT07581561
NCT07581561已完成不适用

Determination of Factors Affecting Success in Unilateral Spinal Anesthesia: A Prospective Observational Study

Izmir City Hospital1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
318
试验地点
1

研究概览

简要总结

This prospective observational study aims to determine the factors affecting the success of unilateral spinal anesthesia in patients undergoing orthopedic lower extremity surgery. Unilateral spinal anesthesia is preferred to minimize unwanted effects such as hypotension and to provide more stable hemodynamic conditions, especially in vulnerable patient populations.

Unilateral spinal anesthesia is defined as achieving sensory and motor block predominantly on the operated side without significant contralateral spread. However, the factors influencing the success of this technique have not been fully clarified.

This study will evaluate various patient-related and procedure-related factors, including age, sex, body mass index, patient positioning, needle type and orientation, injection technique and local anesthetic dose. The primary outcome is the success of unilateral spinal anesthesia, defined as the absence of contralateral block.

The results of this study are expected to contribute to improving clinical practice by identifying major and minor factors affecting block success and optimizing anesthesia techniques.

详细描述

This prospective observational study is designed to investigate the factors influencing the success of unilateral spinal anesthesia in patients undergoing lower extremity orthopedic surgery.

Spinal anesthesia is widely used in lower extremity procedures; however, it may be associated with hemodynamic instability such as hypotension. Unilateral spinal anesthesia has been proposed as a technique to limit sympathetic blockade and maintain more stable hemodynamic conditions. Despite its advantages, the determinants of successful unilateral block remain unclear.

Patients aged between 18 and 65 years with American Society of Anesthesiologists (ASA) physical status I-III who are scheduled for elective lower extremity surgery will be included in the study after providing written informed consent. This study will be conducted in a single tertiary care center.

No intervention will be performed by the investigator. All anesthesia procedures will be carried out according to routine clinical practice. The investigator will record patient demographics, including age, sex, height, weight, and body mass index.

Procedure-related variables such as patient positioning, spinal needle type, needle orientation, injection speed, level of injection, local anesthetic type and dose will be recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients aged 18-65 years
  • ASA physical status I-III
  • Undergoing elective unilateral lower extremity surgery under spinal anesthesia
  • Provided written informed consent

排除标准

  • ASA IV patients
  • Known allergy to local anesthetics
  • Contraindications to spinal anesthesia
  • Decompensated congestive heart failure
  • Hemodynamic instability (including sepsis, septic shock, or need for inotropic support)
  • Pregnancy
  • Patients with vertebral anomalies (e.g., scoliosis, vertebral fractures) preventing proper positioning

研究者

发起方
Izmir City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Derya Arslan Yurtlu

Professor of Anesthesiology

Izmir City Hospital

研究点 (1)

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