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

NCT04454203 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-03-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Amanda Kumar, MD, PhD · Duke University

  • William M Bullock, MD, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2027-02-01
Completion
2027-02-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04454203 on ClinicalTrials.gov