Injection of numbing medication to reduce high blood pressure during ankle surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized double-blind study aims to evaluate the effectiveness of an ultrasound-guided peri-arterial injection of local anesthetic, specifically mepivacaine, in reversing ischemic hypertension caused by prolonged tourniquet use during total ankle arthroplasty. Participants will receive either the local anesthetic or saline injection near the femoral artery to assess its impact on blood pressure during surgery. The study will monitor patients for 24 hours post-injection to determine the efficacy of the treatment in managing tourniquet-associated hypertension.

Why it matters

Who can join: the full rules

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

Where it's running

• Duke University Hospital
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Amanda Kumar, MD, PhD — Duke University
• Study coordinator: William M Bullock, MD, PhD
• Email: william.bullock@duke.edu
• Phone: 919-681-6437

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.