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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion

Intervention / Treatment
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* Drug: Mepivacaine
* Drug: Saline
* Procedure: Perifemoral Injection of Local Anesthetic
* Procedure: Perifemoral Injection of Local Anesthetic


Participation Criteria
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Eligibility Criteria
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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: ASA 4 or 5 Diagnosis of chronic pain Daily chronic opioid use (over 3 months of continuous opioid use). Inability to communicate pain scores or need for analgesia. Infection at the site of block placement Age under 18 years old or greater than 75 years old Pregnant women (as determined by standard of care day-of surgery urine bHCG) Intolerance/allergy to local anesthetics Weight <50 kg Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mepivacaine Block Group<br>Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter. | Drug: Mepivacaine<br>* An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.<br>* Other names: Carbocaine;Procedure: Perifemoral Injection of Local Anesthetic<br>* Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.<br>* Other names: Femoral Periarterial Injection;|
| Placebo Comparator: Saline Sham Group<br>Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter. | Drug: Saline<br>* An infiltration of saline superomedially to the femoral artery via perineural catheter.<br>* Other names: Salt water placebo;Procedure: Perifemoral Injection of Local Anesthetic<br>* Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.<br>* Other names: Femoral Periarterial Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tourniquet hypertension as measured by systolic blood pressure | Infiltrating study drug to reverse intraoperative tourniquet hypertension | From time of injection to 30 minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Perioperative start until 2 hours after admission to PACU | 
| Opioid consumption | Perioperative opioid consumption as measured in oral morphine equivalents (OMEs) | Perioperative start until 2 hours after admission to PACU | 
| Quadriceps motor function | Gross quadriceps motor function as measured by leg extension | 1 hour after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perifemoral, Tourniquet, Mepivacaine, Tourniquet Hypertension