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

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.

Study Overview

• Status: Recruiting
• Conditions: Total Ankle Arthroplasty; Tourniquet Hypertension; Intraoperative Hypertension; Ankle Fusion
• Intervention / Treatment: Drug: Mepivacaine; Procedure: Perifemoral Injection of Local Anesthetic; Procedure: Perifemoral Injection of Local Anesthetic; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: William M Bullock, MD, PhD; Phone Number: 919-681-6437; Email: william.bullock@duke.edu
• Study Contact Backup: Name: Jeff C Gadsden, MD; Phone Number: 919-681-6437; Email: jeff.gadsden@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Hospital
      • Contact: William M Bullock, MD, PhD; Phone Number: 919-681-6437; Email: william.bullock@duke.edu
      • Contact: Amanda Kumar, MD; Phone Number: 919-681-6437; Email: amanda.kumar@duke.edu
      • Principal Investigator: Amanda Kumar, MD
      • Sub-Investigator: William M Bullock, MD, PhD
      • Sub-Investigator: Jeff C Gadsden, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mepivacaine Block Group; Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.	Drug: Mepivacaine; An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.; Other Names: Carbocaine; 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.; Other Names: Femoral Periarterial Injection; 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.; Other Names: Femoral Periarterial Injection
Placebo Comparator: Saline Sham Group; Infiltration of salt water (saline) above and beside the femoral artery through a 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.; Other Names: Femoral Periarterial Injection; 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.; Other Names: Femoral Periarterial Injection; Drug: Saline; An infiltration of saline superomedially to the femoral artery via perineural catheter.; Other Names: Salt water placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Amanda Kumar, MD, PhD, Duke University; Study Director: William M Bullock, MD, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 3, 2027

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Tourniquet; Mepivacaine; Perifemoral; Tourniquet Hypertension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Mepivacaine; Sodium Chloride
• Other Study ID Numbers: Pro00104144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No