CompletedPhase 4

Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension

United States31 participantsStarted 2018-05-03

Plain-language summary

The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. ASA 4 or 5
. Diagnosis of chronic pain
. Daily chronic opioid use (over 3 months of continuous opioid use).
. Inability to communicate pain scores or need for analgesia.
. Infection at the site of block placement
. Age under 18 years old or greater than 75 years old
. Pregnant women (as determined by standard of care day-of surgery urine bHCG)
. Intolerance/allergy to local anesthetics

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects Experiencing Tourniquet Hypertension

Timeframe: Intraoperatively (~3 hours)

Trial details

NCT IDNCT03390426

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-27

Results submitted2019-10-08

View on ClinicalTrials.gov More Tourniquet Hypertension trials