CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Mepivacaine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03390426
NCT03390426Phase 4Completed

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

Duke University·interventional·Posted Jan 4, 2018·Updated May 5, 2021

In Brief

A Phase 4 clinical trial evaluating Mepivacaine, Perifemoral Injection of Local Anesthetic, and 1 other intervention for Tourniquet Hypertension and 3 related conditions. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2018
Enrollment StartMay 3, 2018
Primary CompletionOct 27, 2018
Study CompletionOct 28, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.5 years ago

Interventions

Mepivacainedrug

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

Perifemoral Injection of Local Anestheticprocedure

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

Salinedrug

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