Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
Condition: Tourniquet Hypertension; Intraoperative Hypertension; Total Ankle Arthroplasty; Ankle Fusion
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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. Efficacy will be
      determined by analyzing incidence of intraoperative ischemic hypertension, defined as >30%
      increase in systolic blood pressure, associated with tourniquet inflation times greater than
      90 minutes. The study will involve a total of 30 patients (15 in each group) and with a power
      of 80% to detect a 50% difference. The patients involved in the study will be ASA 1-3
      patients who are undergoing either TAA or foot fusion surgeries. Patients will receive
      standard of care for their anesthesia, which at Duke Hospital includes placement of popliteal
      and saphenous perineural catheters and a general anesthetic with a laryngeal mask airway.
      Patients will be randomized to receive femoral peri-arterial injection with either 1.5%
      mepivacaine with 1:400,000 epinephrine or 0.9% saline which will be performed preoperatively
      at time of perineural catheter placement. Patients will assume standard risk associated with
      nerve blocks, including theoretical risk of nerve damage and local anesthetic systemic
      toxicity. Possible benefits include improved intraoperative hemodynamic stability, decreased
      intraoperative opioid and antihypertensive medications, and decreased tourniquet associated
      pain post-operatively.
    

Intervention name(s): Mepivacaine; Perifemoral Injection of Local Anesthetic; Saline
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): An ultrasound guided injection of mepivacaine superomedially to the femoral artery.; An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.; An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
Other intervention name(s): Carbocaine; Femoral periarterial injection; Salt Water placebo
Intervention MeSH terms: Anesthetics; Mepivacaine; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Perifemoral; Tourniquet; Mepivacaine; Tourniquet Hypertension