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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 statusNot yet recruiting
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

Locations

This trial has no locations.

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

This trial is not recruiting at the moment. You can still explore other options: