Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07241572
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Ankara, Turkey (Türkiye)
Location status: Recruiting
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High sensitive Troponin I used to predict myocardial damage
Time frame: 01.09.2025-10.01.2026
peroperative High sensitive Troponin I
Time frame: 01.09.2025-11.01.2026
postoperative 24th hour High sensitive Troponin I
Time frame: 01.09.2025-12.01.2026
postoperative 48th hour High sensitive Troponin I
Time frame: 01.09.2025-10.01.2026
intraoperative blood pressure (mmHg)
Time frame: 01.09.2025-10.01.2026
intraoperative oxygen saturation (%)
Time frame: 01.09.2025-10.01.2026
heart rate (/min)
Time frame: 01.09.2025-10.02.2026
Sudden myocardial infarction occurring during the operation or within 1 month after the operation
Time frame: 01.09.2025-11.02.2026
Cerebrovascular accident occurring during the operation or within 1 month after the operation
Time frame: 01.09.2025-12.02.2026
rehospitalization during the operation and within 1 month after the operation
Time frame: 01.09.2025-13.02.2026
Death during surgery or within 1 month after surgery
Contact information is provided by the study sponsor or research team.
Harun Zengin
CONTACT
Semih Baskan
CONTACT
Ankara City Hospital Bilkent
Other
Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-knee Lower Extremity Surgery With Peripheral Nerve Block
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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