drugset / Trial / NCT03390426

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

NCT03390426 ↗

Phase 4 Completed 31 enrolled Duke University
RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

Start
2018-05-03
Primary completion
2018-10-27
Completion
2018-10-28

Outcome

Met primary endpoint

paper TH was present in 93.3% of sham patients versus 33.3% of block patients. PMID 33431616 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Mepivacaine Other / unclassified 1.5 % Other
Subject Mepivacaine Other / unclassified 15 ml Other

Indications

No indication recorded.