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NCT Number: NCT07548567

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University General Hospital Attikon

Athens, 124 61, Greece

Location status: Recruiting

Location contact

LAMPRINI BANASIOU

CONTACT

[email protected]

+306981809083

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral artery block - short-axis

Procedure

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

Femoral artery block - long-axis

Procedure

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

Normal saline injection (control)

Other

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

Primary outcomes

  1. Incidence of tourniquet-induced hypertension

    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.

Secondary outcomes

  1. Heart rate

    Time frame: From tourniquet inflation to 90 minutes intraoperatively

    Changes in heart rate during tourniquet application at predefined time points.

  2. Intraoperative esmolol consumption

    Time frame: Intraoperative period

    Total dose of esmolol administered for treatment of hypertension during surgery.

  3. Intraoperative remifentanil consumption

    Time frame: Intraoperative period

    Total remifentanil dose administered during surgery.

  4. Postoperative pain score (VAS)

    Time frame: 0-60 minutes postoperative

    Pain intensity measured using Visual Analog Scale (0-10) in the recovery unit.

  5. Morphine consumption in recovery unit

    Time frame: 0-60 minutes postoperative

    Total morphine dose required for rescue analgesia in the postoperative recovery period.

  6. Femoral nerve block spread

    Time frame: Immediate postoperative period

    Incidence of unintended femoral nerve blockade assessed by quadriceps strength and sensory testing.

  7. Saphenous nerve block spread

    Time frame: Immediate postoperative period

    Incidence of sensory block in saphenous nerve distribution assessed by pinprick test.

  8. Imaging time

    Time frame: During FAB block procedure

    Time from ultrasound probe placement to optimal image acquisition.

  9. Needling time

    Time frame: During FAB block procedure

    Time from needle insertion to completion of local anesthetic or saline injection.

  10. Total block performance time

    Time frame: During FAB block procedure

    Total time required for ultrasound imaging, needle placement and completion of local anesthetic or saline injection.

Study contacts

Contact information is provided by the study sponsor or research team.

LAMPRINI BANASIOU

CONTACT

[email protected]

+306981809083

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Jul 6, 2026

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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