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Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension

NCT03390426 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-05-05

Study results available
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Summary

The purpose of this prospective randomized double-blind study is to determine if the novel technique of ultrasound guided peri-arterial injection of local anesthetic around the femoral artery decreases ischemic hypertension associated with prolonged lower extremity tourniquet time during total ankle arthroplasty (TAA) and foot fusion surgeries. Patients will be randomized 1:1 to receive either local anesthetic or saline, which will be injected superomedially to the femoral artery in an attempt to block sympathetic afferents and decrease tourniquet associated hypertension intraoperatively.

Conditions

  • Tourniquet Hypertension
  • Intraoperative Hypertension
  • Total Ankle Arthroplasty
  • Ankle Fusion

Interventions

DRUG

Mepivacaine

An ultrasound guided injection of mepivacaine superomedially to the femoral artery.

PROCEDURE

Perifemoral Injection of Local Anesthetic

An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.

DRUG

Saline

An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.

Sponsors & Collaborators

Principal Investigators

  • William M Bullock · Assistant Professor

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
2018-05-03
Primary Completion
2018-10-27
Completion
2018-10-28
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 NCT03390426 on ClinicalTrials.gov