此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Predictors of Unilateral Spinal Block Success (UNISS)

2026年5月6日 更新者:Derya Arslan Yurtlu、Izmir City Hospital

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

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.

研究概览

详细说明

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.

Block characteristics will be assessed intraoperatively, including sensory and motor block distribution. The primary outcome is defined as successful unilateral spinal anesthesia, characterized by the absence of contralateral sensory block. Secondary outcomes include factors associated with block success and variability in block characteristics.

Data will be collected using standardized case report forms and analyzed to identify factors influencing the success of unilateral spinal anesthesia. The results of this study are expected to contribute to optimizing anesthesia techniques and improving patient safety.

研究类型

观察性的

注册 (实际的)

318

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients aged 18-65 years with ASA physical status I-III undergoing elective unilateral lower extremity surgery under spinal anesthesia in a single tertiary care center.

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
patients undergoing unilateral spinal anesthesia
Patients aged 18-65 years with ASA physical status I-III undergoing elective unilateral lower extremity surgery under spinal anesthesia.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Unilateral Spinal Block Success Rate
大体时间:Intraoperative period (within first 30 minutes after spinal anesthesia
Successful unilateral spinal anesthesia defined as the absence of contralateral sensory block, assessed by pinprick test and bromage scale within the first 20 minutes after spinal anesthesia.
Intraoperative period (within first 30 minutes after spinal anesthesia

次要结果测量

结果测量
措施说明
大体时间
Rate of unilateral spinal anesthesia success by age
大体时间:Intraoperative period
Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Intraoperative period
Rate of unilateral spinal anesthesia success by BMI
大体时间:Intraoperative period
Proportion (%) of patients achieving unilateral spinal anesthesia success across age groups.
Intraoperative period
Rate of unilateral spinal anesthesia success by position
大体时间:Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by patient positioning during injection (lateral vs sitting).
Intraoperative period
Rate of unilateral spinal anesthesia success by needle type
大体时间:Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by spinal needle type (Quincke vs pencil-point).
Intraoperative period
Rate of unilateral spinal anesthesia success by needle gauge
大体时间:Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by needle gauge.
Intraoperative period
Rate of unilateral spinal anesthesia success by local aneshtetic dose
大体时间:Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by administered local anesthetic dose (mg).
Intraoperative period
Rate of unilateral spinal anesthesia success by injection speed
大体时间:Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by injection speed category (faster vs ≤1 mL/5 s).
Intraoperative period
Sensory Block Level and Distribution
大体时间:Intraoperative period
Assessment of sensory block level (dermatomal level) and comparison between operated and non-operated sides.
Intraoperative period
Rate of unilateral spinal anesthesia success by intervertebral level of spinal injection
大体时间:Intraoperative period
Proportion (%) of unilateral spinal anesthesia success by intervertebral level (L1-2,L2-3,L3-L4 ,L4-L5).
Intraoperative period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Derya Arslan Yurtlu, MD、İzmir City Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月10日

初级完成 (实际的)

2026年2月1日

研究完成 (实际的)

2026年2月1日

研究注册日期

首次提交

2026年4月9日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月6日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared due to patient confidentiality and institutional data protection policies

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅