Long-axis femoral artery block to reduce tourniquet pain and hypertension in below-knee fracture surgery
Official 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
Run by National and Kapodistrian University of Athens · NCT07548567 · Data updated 2026-11-12
This trial tests whether a long-axis ultrasound-guided femoral artery block can lessen tourniquet-induced hypertension and pain in adults having below-the-knee fracture surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens) |
| Status | Recruiting |
| Started | June 3, 2026 |
| Main results expected | October 2027 |
| Study ends | February 2028 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07548567 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with ASA I–III undergoing below-the-knee fracture surgery requiring a tourniquet for at least 45 minutes.
✕Probably not a fit
Patients with contraindications to regional blocks, uncontrolled hypertension, or those not receiving ropivacaine for the block may not benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind study compares three groups: long-axis femoral artery block, short-axis femoral artery block, and a saline control, all in addition to standard anesthesia for below-the-knee fracture surgery with a tourniquet. The goal is to see if the long-axis approach provides superior sympathetic blockade and better hemodynamic stability compared with the short-axis approach and no block. Primary outcome focuses on tourniquet-induced hypertension, with secondary outcomes including analgesic needs, pain scores, block characteristics, and procedure performance. Participants are adults with ASA I–III undergoing surgery requiring tourniquet application for at least 45 minutes, receiving sciatic nerve block and TIVA; randomization is in a 1:1:1 ratio across the three groups. The study is conducted at University General Hospital Attikon, under the National and Kapodistrian University of Athens.
Why it matters
Potential benefit: If successful, the long-axis FAB could offer better control of tourniquet-related hypertension and pain, improving perioperative safety and comfort.
How similar studies have gone: Prior FAB work used a short-axis approach; this study explores a novel long-axis technique, with existing data suggesting potential benefit but not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University General Hospital Attikon
Athens, Greece Recruiting
Study contacts
- Study coordinator: Lamprini Banasiou
- Email: banasiou_labrini@yahoo.com
- Phone: +306981809083
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.