跳至主要内容
临床试验/NCT07241572
NCT07241572招募中不适用

Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-knee Lower Extremity Surgery With Peripheral Nerve Block

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
54
试验地点
1
主要终点
High sensitive Troponin I

研究概览

简要总结

The aim of this observational study was to detect myocardial damage by monitoring high-sensitive troponin I levels in patients undergoing below-knee extremity surgery with peripheral nerve block.

The primary question it aims to answer is:

How effective are peroperative high-sensitive troponin I levels in predicting myocardial damage?

High-sensitive troponin I levels will be monitored intraoperatively and at 24 and 48 hours postoperatively.

详细描述

Peripheral nerve blocks are becoming increasingly popular in foot and ankle surgery. Patients undergoing peripheral nerve blocks have advantages such as shorter hospital stays, better postoperative pain relief, lower costs, and less opioid use.

A review of current literature revealed that myocardial damage has not been investigated in patients scheduled for below-knee lower extremity surgery. Therefore, we aimed to detect myocardial damage by monitoring high-sensitive troponin I levels, which is considered the most sensitive and effective test according to AHA/ACC (American College of Cardiology and American Heart Association) guidelines at our hospital. The secondary aim of the study was to determine which parameters correlate with myocardial damage.

Preoperatively, the patient's hemogram, biochemistry, and hsTroponin I measurements, all of which were requested during the preparation phase, will be recorded.

During the operation, the type of anesthesia, the amount of local anesthetic and adjuvant medication used for peripheral nerve blockade will be recorded.

Intraoperatively, routine anesthetic monitoring (SpO2, blood pressure, ECG, heart rate), intraoperative presence and duration of hypotension, need for inotropic support, total dose (if any), presence and duration of tachycardia and bradycardia, fluid volume administered, urine output, and operation time 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 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients over 18 years of age
  • •Patients undergoing below-knee lower extremity surgery
  • •Patients with ASA classifications I, II, III, and IV
  • •Patients who have consented before the procedure
  • •Patients who are literate and able to give consent

排除标准

  • •Patients in whom regional anesthesia is contraindicated
  • •Patients who refuse to participate in the study

结局指标

主要结局

High sensitive Troponin I

时间窗: 01.09.2025-12.01.2026

postoperative 48th hour High sensitive Troponin I

次要结局

  • hemodynamic parameters 2(01.09.2025-10.01.2026)
  • hemodynamic parameters 1(01.09.2025-10.01.2026)
  • hemodynamic parameters 3(01.09.2025-10.01.2026)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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