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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Diabetes Complication
• Intervention / Treatment: Diagnostic test: high sensitive Troponin I

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 54

Contacts and Locations

• Study Contact: Name: Harun Zengin; Phone Number: 05422358195; Email: harunzengin71@gmail.com
• Study Contact Backup: Name: Semih Baskan; Phone Number: 05326030675; Email: drsemkan@yahoo.com

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • Recruiting
    • Ankara Bilkent City Hospital
    • Contact: Harun Zengin; Phone Number: 05422358195; Email: harunzengin71@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing below-knee lower extremity surgery under peripheral nerve blockade

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All patients undergoing elective below-knee lower extremity surgery; All patients undergoing below-knee lower extremity surgery will have their high-sensitive troponin I levels monitored preoperatively and at the 24th and 48th hours postoperatively. Intraoperatively, routine anesthetic monitoring (SpO2, blood pressure, ECG, apical heart rate) will be recorded. The presence and duration of intraoperative hypotension, the need for inotropic support, the total dose (if any), the presence and duration of tachycardia and bradycardia, the amount of fluid administered, urine output, and the duration of surgery will be recorded. 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).

Diagnostic test: high sensitive Troponin I; High sensitive Troponin I used to predict myocardial damage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High sensitive Troponin I	peroperative High sensitive Troponin I	01.09.2025-10.01.2026
High sensitive Troponin I	postoperative 24th hour High sensitive Troponin I	01.09.2025-11.01.2026
High sensitive Troponin I	postoperative 48th hour High sensitive Troponin I	01.09.2025-12.01.2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemodynamic parameters 1	intraoperative blood pressure (mmHg)	01.09.2025-10.01.2026
hemodynamic parameters 2	intraoperative oxygen saturation (%)	01.09.2025-10.01.2026
hemodynamic parameters 3	heart rate (/min)	01.09.2025-10.01.2026

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
unexpected events	Sudden myocardial infarction occurring during the operation or within 1 month after the operation	01.09.2025-10.02.2026
unexpected events	Cerebrovascular accident occurring during the operation or within 1 month after the operation	01.09.2025-11.02.2026
unexpected events	rehospitalization during the operation and within 1 month after the operation	01.09.2025-12.02.2026
unexpected events	Death during surgery or within 1 month after surgery	01.09.2025-13.02.2026

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Harun Zengin, harunzengin71@gmail.com

Publications and helpful links

General Publications

• Park J, Hyeon CW, Lee SH, Kim J, Kwon JH, Yang K, Min JJ, Lee JH, Lee SM, Yang JH, Song YB, Hahn JY, Choi JH, Choi SH, Kim K, Ahn J, Gwon HC. Mildly Elevated Cardiac Troponin below the 99th-Percentile Upper Reference Limit after Noncardiac Surgery. Korean Circ J. 2020 Oct;50(10):925-937. doi: 10.4070/kcj.2020.0088. Epub 2020 Jul 24.
• Horr S, Reed G, Menon V. Troponin elevation after noncardiac surgery: Significance and management. Cleve Clin J Med. 2015 Sep;82(9):595-602. doi: 10.3949/ccjm.82a.15076.
• Devereaux PJ, Szczeklik W. Myocardial injury after non-cardiac surgery: diagnosis and management. Eur Heart J. 2020 May 1;41(32):3083-3091. doi: 10.1093/eurheartj/ehz301.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): January 10, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Estimated): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: myocardial injury; MINS; Troponın I; diabetic neuropaty
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Diabetes Mellitus; Myocardial Ischemia; Diabetes Complications
• Other Study ID Numbers: E2-25-11354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: general demographic information, contact information, work names

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No