Clinical trial NCT04454203: Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Official title: Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Tourniquet Hypertension
Intraoperative Hypertension
Total Ankle Arthroplasty
Ankle Fusion
Keywords: Perifemoral
Tourniquet
Mepivacaine
Tourniquet Hypertension
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Change in tourniquet hypertension as measured by systolic blood pressure
timeFrame: From time of injection to 30 minutes after injection
Secondary outcomes:
measure: Pain Scores (NRS11)
timeFrame: Perioperative start until 2 hours after admission to PACU
measure: Opioid consumption
timeFrame: Perioperative start until 2 hours after admission to PACU
measure: Quadriceps motor function
timeFrame: 1 hour after extubation
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Amanda Kumar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: William M Bullock, MD, PhD
role: STUDY_DIRECTOR
References: