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临床试验/NCT06459986
NCT06459986招募中不适用

The Duration of Spinal Anaesthesia - a Prospective Observational Cohort Study

Nordsjaellands Hospital2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
2
主要终点
Duration of spinal anasthesia 1

研究概览

简要总结

Today, surgery in an ambulatory setting is preferred for many reasons. Total hip and knee arthroplasty (THA and TKA) are now procedures where patients can be sent home on the same day of the surgical procedure. However, this requires substantial knowledge of factors affecting the length of hospital stay. In this prospective, observational cohort study, we will investigate factors that affect the duration of spinal anaesthesia which is often used in THA and TKA. The aim is to gather enough data to be able to determine how local anaesthetic volume and dose affect the duration of spinal anaesthesia. This will enable us to decide whether spinal anaesthesia is a good option when performing TKA and THA in an ambulatory setting.

详细描述

With the increasing health care cost and the scarcity of nursing staff, there is considerable focus on providing surgery in an ambulatory setting. Total hip and knee arthroplasty (THA and TKA) are now procedures where selected patients are sent home on the same day after the procedure. Therefore, knowledge of key factors affecting the length of stay is important. One factor is the method of anaesthesia used for the operative procedure.

Spinal anaesthesia is often used for THA and TKA and has several advantages compared to general anaesthesia. However, spinal anaesthesia also has drawbacks, because it reduces the force in the legs, hindering early mobilisation. There are no good data on the duration of spinal anaesthesia. Compared to the past, there has been a shift towards using lower doses of local anaesthetic (LA) injected into the subarachnoid space. Theoretically, this should result in a shorter duration of anaesthesia, and this would be of value in an ambulatory setting. However, if the variation in the duration is high and therefore not predictable for the individual patient, spinal anaesthesia has limitations in the ambulatory setting.

The objective of the present study is to prospectively collect data on the type and dose of LA injected into the subarachnoid space and the duration of spinal anaesthesia in participants scheduled for orthopaedic surgery in spinal anaesthesia. We hypothesise that the mean duration of spinal anaesthesia is positively correlated to the dose of LA injected into the subarachnoid space.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for elective orthopaedic surgical procedures performed in spinal anaesthesia

排除标准

  • Age < 18 years
  • Anticoagulant medication therapy not paused according ESAIC/ESRA 2022 guidelines
  • Local infection at the lumbar puncture site
  • Bleeding disorder
  • Unable to cooperate with the spinal anaesthesia procedure.

结局指标

主要结局

Duration of spinal anasthesia 1

时间窗: 12 hours

Time from subarachnoid LA administration to Bromage score \< 3

Duration of spinal anaesthesia 2

时间窗: 12 hours

Time from subarachnoid LA administration to Bromage score = 1

次要结局

未报告次要终点

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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