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临床试验/NCT05840458
NCT05840458招募中不适用

Effect of Systemic Analgesia and Systemic Analgesia Associated With Pericapsular Nerve Block in Proximal Femoral Fractures

Hospital Sirio-Libanes1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年4月1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
21
试验地点
1
主要终点
Functional impairment

研究概览

简要总结

Proximal femoral fractures commonly occur above 50 years and regional anesthesia could be a complement in the perioperative treatment of the patients. The use of pericapsular nerve group block (PENG Block) has been proposed to reduce pain. However, no studies have explored the efficient of the systemic analgesia associated with PENG Block in functional limitation in the preoperative period. In this sense, the main goal of this study is to evaluate the effectiveness of systemic analgesia associated with PENG Block in patients with proximal femoral fractures in the period preceding the surgical procedure.

详细描述

Focus on functional capacity will be measured by the Activity Measure for Post-Acute Care (AM-PAC) short version of the "6 Clicks", pain intensity will be assessed using the numerical rating scale, and opioid consumption. This study will include 21 patients admitted to the Emergency Room with proximal femoral fractures.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with unilateral proximal femoral fractures admitted to the emergency room of the Hospital Sírio-Libanes,
  • aged 18-105 years
  • with the American Society of Anesthesiology (ASA) physical status I, II, or III.

排除标准

  • allergy to metamizole and/or ropivacaine
  • history of mental disorders
  • presence of chronic pain as assessed using the Douleur Neuropathique 4 (DN4) questionnaire

结局指标

主要结局

Functional impairment

时间窗: 12 hours after intervention

The Short-form of Activity Measure for Post-Acute Care (AM-PAC- "6 clicks") is a measure of basic patient mobility will be used. Higher scores mean better outcomes. Minimum 6 points, maximum 26 points.

次要结局

  • Pain levels(12 hours after performing the PENG block)
  • Opioid consumption(24 hours after performing the PENG Block)

研究者

发起方
Hospital Sirio-Libanes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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