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临床试验/NCT05819723
NCT05819723已完成不适用

Analgesia Produced by Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries

Ain Shams University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
post operative delirium

研究概览

简要总结

Postoperative pain is a significant risk factor for delirium. This clinical trial will search whether analgesia produced by erector spinae block in elderly patients undergoing hip fracture surgeries reduces delirium or not!

详细描述

This randomized controlled trial will include 120 elderly patients American Society of Anesthesiologists physical status I-II, aged more than 60 years old and undergoing fracture hip surgeries.

all patients will be examined for preoperative cognitive impairment using the short form of the Confusion Assessment Method Survey (CAM) and the long form will be used postoperatively.

The CAM scores is an algorithm that consists of four features:

(i) Acute and fluctuating variation in mental status, (ii) Inattention, (iii) Incoherent or disorganized thinking, and (iv) Altered level of consciousness.CAM scores indicate delirium if the first two features are present and either the third or fourth feature is present.

Patients with a delirium of CAM score>1 will be excluded from the study. also, patients will be asked to rate their baseline pain levels using the numeric rating scales (NRS) from "no pain" to "worst possible pain". patients will be randomly divided into two equal groups Group 1: spinal anaesthesia only. Group 2: spinal anaesthesia with erector spinae block. In both groups, basic monitoring in the form of non-invasive blood pressure (NIBP), pulse oxygen saturation (SPO2)and 5-lead electrocardiogram (ECG) will be attached in the operating room(OR)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >60 years.
  • American Society of Anesthesiologists physical status I, II.
  • Patients undergoing hip fracture surgeries under spinal anaesthesia

排除标准

  • History of neurological or psychiatric disease.
  • Allergy to local anaesthetics.
  • Infection in the injection area.
  • Regular medication with tranquillizers and/or antidepressants.
  • CAM scores II-VI.
  • Delayed fracture surgeries more than 48 hours.
  • Intraoperative blood loss of more than 1000 ml.
  • Patient refusal.

结局指标

主要结局

post operative delirium

时间窗: first days postoperative

occurrence and severity of cognitive dysfunction

次要结局

  • complications from erector spinae block(on the first and the second days postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Maher Hussien, MD

Associate professor of Anesthesia

Ain Shams University

研究点 (2)

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