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A Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07548567
Acronym
FAB
Enrollment
84
Registered
2026-04-23
Start date
2026-06-03
Completion date
2028-02-01
Last updated
2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourniquet Hypertension

Keywords

FAB block, Tourniquet-induced hypertension, Tourniquet pain, Below-knee fracture surgery, Sympathetic blockade, intraoperative hypertension, sciatic nerve block, randomized controlled trial

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREFemoral artery block - short-axis

Ultrasound-guided femoral artery block using short-axis in-plane technique with 10 mL ropivacaine 0.5%.

PROCEDUREFemoral artery block - long-axis

Ultrasound-guided femoral artery block using long-axis in-plane technique with 10 mL ropivacaine 0.5%.

OTHERNormal saline injection (control)

Ultrasound-guided femoral artery injection using 10 mL 0.9% normal saline.

Sponsors

National and Kapodistrian University of Athens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 years * Physical status ASA I-III * Fluent in Greek or English * Scheduled surgery: below-knee fractures * Tourniquet duration ≥45 minutes

Exclusion criteria

* Refusal to participate * Local inflammation at block site * Known allergy to study drugs * Morbid obesity (BMI \>40) * Communication inability * Systemic neurological disease affecting peripheral nerves * Chronic pain therapy * Diabetic neuropathy * Uncontrolled hypertension

Design outcomes

Primary

MeasureTime frameDescription
Incidence of tourniquet-induced hypertensionFrom tourniquet inflation to 90 minutes intraoperativelyTourniquet-induced hypertension defined as an increase in systolic blood pressure greater than 30% from baseline values during tourniquet application.

Secondary

MeasureTime frameDescription
Heart rateFrom tourniquet inflation to 90 minutes intraoperativelyChanges in heart rate during tourniquet application at predefined time points.
Intraoperative esmolol consumptionIntraoperative periodTotal dose of esmolol administered for treatment of hypertension during surgery.
Intraoperative remifentanil consumptionIntraoperative periodTotal remifentanil dose administered during surgery.
Postoperative pain score (VAS)0-60 minutes postoperativePain intensity measured using Visual Analog Scale (0-10) in the recovery unit.
Morphine consumption in recovery unit0-60 minutes postoperativeTotal morphine dose required for rescue analgesia in the postoperative recovery period.
Femoral nerve block spreadImmediate postoperative periodIncidence of unintended femoral nerve blockade assessed by quadriceps strength and sensory testing.
Saphenous nerve block spreadImmediate postoperative periodIncidence of sensory block in saphenous nerve distribution assessed by pinprick test.
Imaging timeDuring FAB block procedureTime from ultrasound probe placement to optimal image acquisition.
Needling timeDuring FAB block procedureTime from needle insertion to completion of local anesthetic or saline injection.
Total block performance timeDuring FAB block procedureTotal time required for ultrasound imaging, needle placement and completion of local anesthetic or saline injection.

Countries

Greece

Contacts

CONTACTLAMPRINI BANASIOU
banasiou_labrini@yahoo.com+306981809083

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 7, 2026