Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-Knee Lower Extremity Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: high sensitive Troponin I.
- Who it may be relevant to
- Registry conditions: Myocardial Ischemia, Diabetes Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-knee Lower Extremity Surgery With Peripheral Nerve Block
Overview
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.
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).
Interventions
- Diagnostic test high sensitive Troponin I
High sensitive Troponin I used to predict myocardial damage
Primary outcome measures
- High sensitive Troponin I [Time frame: 01.09.2025-10.01.2026]
- High sensitive Troponin I [Time frame: 01.09.2025-11.01.2026]
- High sensitive Troponin I [Time frame: 01.09.2025-12.01.2026]
Secondary outcome measures (3)
- hemodynamic parameters 1 [Time frame: 01.09.2025-10.01.2026]
- hemodynamic parameters 2 [Time frame: 01.09.2025-10.01.2026]
- hemodynamic parameters 3 [Time frame: 01.09.2025-10.01.2026]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Ankara Bilkent City Hospital — Ankara
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. PMID 32812403
- 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. PMID 26366956
- 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. PMID 31095334
Identifiers
NCT: NCT07241572 · E2-25-11354