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Recruiting NCT07548567

NCT07548567 A Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery

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Clinical Trial Summary
NCT ID NCT07548567
Status Recruiting
Phase
Sponsor National and Kapodistrian University of Athens
Condition Tourniquet Hypertension
Study Type INTERVENTIONAL
Enrollment 84 participants
Start Date 2026-06-03
Primary Completion 2027-10

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Femoral artery block - short-axisFemoral artery block - long-axisNormal saline injection (control)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 84 participants in total. It began in 2026-06-03 with a primary completion date of 2027-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

LAMPRINI BANASIOU

✉ banasiou_labrini@yahoo.com

📞 +306981809083

Frequently Asked Questions

Who can join the NCT07548567 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Tourniquet Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07548567 currently recruiting?

Yes, NCT07548567 is actively recruiting participants. Contact the research team at banasiou_labrini@yahoo.com for enrollment information.

Where is the NCT07548567 trial being conducted?

This trial is being conducted at Athens, Greece.

Who is sponsoring the NCT07548567 clinical trial?

NCT07548567 is sponsored by National and Kapodistrian University of Athens. The trial plans to enroll 84 participants.

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