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

Phase 4RecruitingNCT04454203

Duke University40 enrolled

Overview

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.

This is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet. 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. Oftentimes the tourniquet causes your blood pressure to go up, but the numbing medication may help return your blood pressure close to its normal level. The rest of your anesthesia care, including other nerve blocks and general anesthetic, will be the same as it would be without participating in the study. You will be enrolled in this study for 24 hours.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Tourniquet Hypertension Intraoperative Hypertension

Interventions

MepivacaineDRUG

An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.

SalineDRUG

An infiltration of saline superomedially to the femoral artery via perineural catheter.

Perifemoral Injection of Local AnestheticPROCEDURE

Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

Perifemoral Injection of Local AnestheticPROCEDURE

Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in tourniquet hypertension as measured by systolic blood pressure

Infiltrating study drug to reverse intraoperative tourniquet hypertension

Time frame: From time of injection to 30 minutes after injection

Secondary Outcomes

Pain Scores (NRS11)

The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

Time frame: Perioperative start until 2 hours after admission to PACU

Opioid consumption

Perioperative opioid consumption as measured in oral morphine equivalents (OMEs)

Time frame: Perioperative start until 2 hours after admission to PACU

Quadriceps motor function

Gross quadriceps motor function as measured by leg extension

Time frame: 1 hour after extubation