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

Launched by DUKE UNIVERSITY · Jun 29, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help manage high blood pressure in the legs that can happen during certain surgeries, like ankle replacements or fusions. Researchers want to find out if using a special technique to inject a local anesthetic near the femoral artery can reduce this high blood pressure caused by a tourniquet, which is a device used to control bleeding during surgery.

To be eligible for this study, participants should be between 18 and 75 years old, speak English, and be in good health (classified as ASA levels 1-3, which means they have no serious health issues). Those who are pregnant, have chronic pain, or are taking opioids regularly will not be included. If you join the study, you can expect to receive either the local anesthetic or a placebo (an inactive substance) during your surgery, and neither you nor the doctors will know which one you received. This helps ensure the results are fair and unbiased. Your participation could help improve pain management techniques for future patients undergoing similar surgeries.

Gender

ALL

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