University General Hospital Attikon
Athens, 124 61, Greece
Location status: Recruiting
NCT Number: NCT07548567
This is a prospective, randomized, double-blind controlled trial evaluating an ultrasound-guided femoral artery block (FAB) using a long-axis in-plane approach compared with a short-axis approach and a control group.
The study will include adult patients (ASA I-III) undergoing below-the-knee fracture surgery with tourniquet application. All patients will receive standardized anesthesia including sciatic nerve block and total intravenous anesthesia.
Participants will be randomized into three groups: short-axis FAB, long-axis FAB, or control (saline injection). The primary aim is to assess the effectiveness of the long-axis FAB in reducing tourniquet-induced hypertension. Secondary outcomes include hemodynamic stability, analgesic requirements, pain scores, block characteristics, and procedural performance metrics.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Athens, 124 61, Greece
Location status: Recruiting
Tourniquet application during lower limb orthopedic surgery is associated with significant hemodynamic responses, including pain and tourniquet-induced hypertension (TH), which may increase perioperative cardiovascular risk. Femoral artery block (FAB) is a novel ultrasound-guided regional anesthesia technique targeting the perivascular sympathetic plexus surrounding the femoral artery to attenuate these responses.
Previous studies have described FAB using a short-axis in-plane ultrasound approach. This study proposes a novel long-axis in-plane ultrasound technique, hypothesizing that longitudinal visualization of the femoral artery may improve anatomical alignment with perivascular sympathetic structures, resulting in more effective sympathetic blockade, improved safety, and enhanced clinical efficacy.
This is a prospective, randomized, double-blind controlled trial including adult patients (ASA I-III) scheduled for below-the-knee fracture surgery requiring tourniquet application for at least 45 minutes. After informed consent and baseline assessment, patients will be randomized into three groups: (1) short-axis FAB with ropivacaine, (2) long-axis FAB with ropivacaine, and (3) control group receiving normal saline injection.
All patients will receive standardized anesthetic management including sciatic nerve block at the popliteal level and total intravenous anesthesia using propofol and remifentanil via Target-Controlled Infusion (TCI) under BIS monitoring. Hemodynamic variables (blood pressure and heart rate) will be recorded at predefined intraoperative and postoperative time points. Tourniquet-induced hypertension will be defined as a >30% increase in systolic blood pressure from baseline.
Secondary outcomes include intraoperative opioid and vasopressor requirements, incidence of femoral and saphenous nerve spread, procedural performance metrics (imaging and needling time), postoperative pain scores (VAS), and opioid consumption in the recovery unit.
Data will be analyzed using repeated-measures and comparative statistical models to evaluate differences between groups over time and between interventions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided femoral artery block using short-axis in-plane technique with 10 mL ropivacaine 0.5%.
Ultrasound-guided femoral artery block using long-axis in-plane technique with 10 mL ropivacaine 0.5%.
Ultrasound-guided femoral artery injection using 10 mL 0.9% normal saline.
Time frame: From tourniquet inflation to 90 minutes intraoperatively
Tourniquet-induced hypertension defined as an increase in systolic blood pressure greater than 30% from baseline values during tourniquet application.
Time frame: From tourniquet inflation to 90 minutes intraoperatively
Changes in heart rate during tourniquet application at predefined time points.
Time frame: Intraoperative period
Total dose of esmolol administered for treatment of hypertension during surgery.
Time frame: Intraoperative period
Total remifentanil dose administered during surgery.
Time frame: 0-60 minutes postoperative
Pain intensity measured using Visual Analog Scale (0-10) in the recovery unit.
Time frame: 0-60 minutes postoperative
Total morphine dose required for rescue analgesia in the postoperative recovery period.
Time frame: Immediate postoperative period
Incidence of unintended femoral nerve blockade assessed by quadriceps strength and sensory testing.
Time frame: Immediate postoperative period
Incidence of sensory block in saphenous nerve distribution assessed by pinprick test.
Time frame: During FAB block procedure
Time from ultrasound probe placement to optimal image acquisition.
Time frame: During FAB block procedure
Time from needle insertion to completion of local anesthetic or saline injection.
Time frame: During FAB block procedure
Total time required for ultrasound imaging, needle placement and completion of local anesthetic or saline injection.
Contact information is provided by the study sponsor or research team.
National and Kapodistrian University of Athens
Other
Turning the Probe, Changing the View: A Novel Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery: A Prospective, Randomized, Double-Blind Controlled Trial
Acronym: FAB
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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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