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

NCT04454203 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro00104144
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourniquet Hypertension; Intraoperative Hypertension; Total Ankle Arthroplasty; Ankle Fusion

Keywords

Perifemoral; Tourniquet; Mepivacaine; Tourniquet Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain Scores (NRS11)

  Perioperative start until 2 hours after admission to PACU

• Opioid consumption

  Perioperative start until 2 hours after admission to PACU

• Quadriceps motor function

  1 hour after extubation

Study Arms (2)

Mepivacaine Block Group

EXPERIMENTAL

Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.

Drug: Mepivacaine; Procedure: Perifemoral Injection of Local Anesthetic

Saline Sham Group

PLACEBO COMPARATOR

Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.

Drug: Saline; Procedure: Perifemoral Injection of Local Anesthetic

Interventions

Mepivacaine DRUG

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

Also known as: Carbocaine

Mepivacaine Block Group

Saline DRUG

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

Also known as: Salt water placebo

Saline Sham Group

Perifemoral Injection of Local Anesthetic PROCEDURE

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

Also known as: Femoral Periarterial Injection

Mepivacaine Block Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Interventions

Mepivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Amanda Kumar, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• William M Bullock, MD, PhD

  Duke University

  STUDY DIRECTOR

Central Study Contacts

William M Bullock, MD, PhD

CONTACT

919-681-6437; william.bullock@duke.edu

Jeff C Gadsden, MD

CONTACT

919-681-6437; jeff.gadsden@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 1, 2020
• Study Start: February 5, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 3, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)