Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Supportive Care
Participants needed
40 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for people aged 18 to 75 who speak English and are having ankle surgery. Participants will receive a local anesthetic to see if it can help lower high blood pressure caused by a tourniquet during surgery.
Are You a Good Fit for This Trial?
Rules you outChronic painDaily chronic opioid usePregnancyIntolerance or allergy to local anesthetics
You may be able to join if
I am 18 to 75 years old.
I speak English.
I am having total ankle arthroplasty.
You may not be able to join if
I have chronic pain.
I use opioids daily for more than 3 months.
I cannot communicate my pain or need for pain relief.
I have an infection where the injection would be given.
I am under 18 or over 75 years old.
I am pregnant.
I am allergic to local anesthetics.
I weigh less than 50 kg.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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. Inabili…
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
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