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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

ConditionTourniquet Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years

Physical status ASA I-III

Fluent in Greek or English

Scheduled surgery: below-knee fractures

Disqualifiers

Refusal to participate

Local inflammation at block site

Known allergy to study drugs

Morbid obesity (BMI >40)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Femoral artery block - short-axis

    Procedure/Surgery

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

  • Femoral artery block - long-axis

    Procedure/Surgery

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

  • Normal saline injection (control)

    Other intervention

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

Treatment groups

84 Participants
are divided into 3 treatment groups
Group A: Short-axis femoral artery blockExperimental treatment 1 intervention
Group B: Long-axis femoral artery blockExperimental treatment 1 intervention
Group C: Saline control injectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of tourniquet-induced hypertension

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

Secondary outcomes

1

Heart rate

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

Time frame
From tourniquet inflation to 90 minutes intraoperatively
2

Intraoperative esmolol consumption

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

Time frame
Intraoperative period
3

Intraoperative remifentanil consumption

Total remifentanil dose administered during surgery.

Time frame
Intraoperative period
4

Postoperative pain score (VAS)

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

Time frame
0-60 minutes postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National and Kapodistrian University of Athens

Lead sponsor

Source ClinicalTrials.gov
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