Overview

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

Status:
Completed
Trial end date:
2018-10-28
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Duke University
Treatments:
Anesthetics
Anesthetics, Local
Mepivacaine
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