NCT07548567

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Feb 2028

First Submitted

Initial submission to the registry

April 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

April 16, 2026

Last Update Submit

April 29, 2026

Conditions

Tourniquet Hypertension

Keywords

FAB blockTourniquet-induced hypertensionTourniquet painBelow-knee fracture surgerySympathetic blockadeintraoperative hypertensionsciatic nerve blockrandomized controlled trial

Outcome Measures

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.

    From tourniquet inflation to 90 minutes intraoperatively

Secondary Outcomes (10)

  • Heart rate

    From tourniquet inflation to 90 minutes intraoperatively

  • Intraoperative esmolol consumption

    Intraoperative period

  • Intraoperative remifentanil consumption

    Intraoperative period

  • Postoperative pain score (VAS)

    0-60 minutes postoperative

  • Morphine consumption in recovery unit

    0-60 minutes postoperative

  • +5 more secondary outcomes

Study Arms (3)

Short-axis femoral artery block

EXPERIMENTAL

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

Procedure: Femoral artery block - short-axis

Long-axis femoral artery block

EXPERIMENTAL

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

Procedure: Femoral artery block - long-axis

Saline control injection

PLACEBO COMPARATOR

Ultrasound-guided femoral artery injection using in-plane technique with 10 mL 0.9% normal saline.

Other: Normal saline injection (control)

Interventions

Femoral artery block - short-axisPROCEDURE

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

Short-axis femoral artery block
Femoral artery block - long-axisPROCEDURE

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

Long-axis femoral artery block
Normal saline injection (control)OTHER

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

Saline control injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Physical status ASA I-III
  • Fluent in Greek or English
  • Scheduled surgery: below-knee fractures
  • Tourniquet duration ≥45 minutes

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 23, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

April 30, 2026

Record last verified: 2026-04