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RecruitingPhase 4

Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time."
  • "Depending on whether you enroll in this study, you may receive an injection of local anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large artery going down your leg)."
  • "This is to see how this injection impacts your blood pressure during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help decrease the bleeding during surgery."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether numbing medicine placed near a major artery in the thigh can lower high blood pressure caused by long use of a tourniquet during leg surgery. A tourniquet is a tight band that limits blood flow. The study is for adults having total ankle replacement surgery.

The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Speak English and be 18 to 75 years old.
  • Be having total ankle replacement surgery.
  • Have an ASA health rating of 1 to 3, meaning you are healthy or have mild to severe illness.

Who can't join

  • Have an ASA health rating of 4 or 5, meaning a life-threatening illness or not expected to survive without surgery.
  • Have long-term pain, or have taken opioid pain medicine daily for more than 3 months.
  • Cannot report your pain level or say when you need pain medicine.
  • Have an infection where the numbing medicine will be placed, or an allergy to or inability to tolerate numbing medicine.
  • Are younger than 18 or older than 75, weigh less than 50 kg (about 110 pounds), or are pregnant based on a urine test on surgery day.
  • Have known or suspected addiction to or misuse of illegal drugs, prescription medicines, or alcohol within the past 2 years.
  • Have uncontrolled anxiety, schizophrenia, or another mental health condition that the study doctor thinks could affect study tests or your ability to follow study instructions.
  • Have a current or past serious health condition that the study doctor thinks could make surgery or recovery more risky.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty. Exclusion Criteria: 1. ASA 4 or 5 2. Diagnosis of chronic pain 3. Daily chronic opioid use (over 3 months of continuous opioid use). 4. Inability to communicate pain scores or need for analgesia. 5. Infection at the site of block placement 6. Age under 18 years old or greater than 75 years old 7. Pregnant women (as determined by standard of care day-of surgery urine bHCG) 8. Intolerance/allergy to local anesthetics 9. Weight \<50 kg 10. Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. 11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance. 12. Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course

Study sites (1)

NC