Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mepivacaine, Saline, Perifemoral Injection of Local Anesthetic, Perifemoral Injection of Local Anesthetic.
- Who it may be relevant to
- Registry conditions: Tourniquet Hypertension, Intraoperative Hypertension, Total Ankle Arthroplasty, Ankle Fusion. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed description
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.
Interventions
- Drug Mepivacaine
An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter. - Drug Saline
An infiltration of saline superomedially to the femoral artery via perineural catheter. - Procedure Perifemoral Injection of Local Anesthetic
Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively. - Procedure Perifemoral Injection of Local Anesthetic
Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.
Primary outcome measures
- Change in tourniquet hypertension as measured by systolic blood pressure [Time frame: From time of injection to 30 minutes after injection]
Secondary outcome measures (3)
- Pain Scores (NRS11) [Time frame: Perioperative start until 2 hours after admission to PACU]
- Opioid consumption [Time frame: Perioperative start until 2 hours after admission to PACU]
- Quadriceps motor function [Time frame: 1 hour after extubation]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Duke University Hospital — Durham
Identifiers
NCT: NCT04454203 · Pro00104144