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NCT Number: NCT07241572

Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-Knee Lower Extremity Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

Harun Zengin

CONTACT

[email protected]

05422358195

About this study

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.

Postoperatively, all patients will be monitored in their ward or intensive care unit. Routine hemogram, biochemistry, and hsTroponin I measurements will be repeated at 24 and 48 hours, and the results will be noted. Postoperative complications will be recorded.

Patients will be followed up for 30 days through the hospital registry and telemedicine at the investigator's discretion, and will be questioned about potential major cardiac events (MACE).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

high sensitive Troponin I

Diagnostic Test

High sensitive Troponin I used to predict myocardial damage

Primary outcomes

  1. High sensitive Troponin I

    Time frame: 01.09.2025-10.01.2026

    peroperative High sensitive Troponin I

  2. High sensitive Troponin I

    Time frame: 01.09.2025-11.01.2026

    postoperative 24th hour High sensitive Troponin I

  3. High sensitive Troponin I

    Time frame: 01.09.2025-12.01.2026

    postoperative 48th hour High sensitive Troponin I

Secondary outcomes

  1. hemodynamic parameters 1

    Time frame: 01.09.2025-10.01.2026

    intraoperative blood pressure (mmHg)

  2. hemodynamic parameters 2

    Time frame: 01.09.2025-10.01.2026

    intraoperative oxygen saturation (%)

  3. hemodynamic parameters 3

    Time frame: 01.09.2025-10.01.2026

    heart rate (/min)

Other outcomes

  1. unexpected events

    Time frame: 01.09.2025-10.02.2026

    Sudden myocardial infarction occurring during the operation or within 1 month after the operation

  2. unexpected events

    Time frame: 01.09.2025-11.02.2026

    Cerebrovascular accident occurring during the operation or within 1 month after the operation

  3. unexpected events

    Time frame: 01.09.2025-12.02.2026

    rehospitalization during the operation and within 1 month after the operation

  4. unexpected events

    Time frame: 01.09.2025-13.02.2026

    Death during surgery or within 1 month after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Harun Zengin

CONTACT

[email protected]

05422358195

Semih Baskan

CONTACT

[email protected]

05326030675

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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