Femoral Peri-arterial Local Anesthetic Injection Decreases Tourniquet Associated Ischemic Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Subjects Experiencing Tourniquet Hypertension
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that will be included in the study are English speaking 18-75 year old ASA 1-3 patients undergoing total ankle arthroplasty.
排除标准
- •Diagnosis of chronic pain
- •Daily chronic opioid use (over 3 months of continuous opioid use).
- •Inability to communicate pain scores or need for analgesia.
- •Infection at the site of block placement
- •Age under 18 years old or greater than 75 years old
- •Pregnant women (as determined by standard of care day-of surgery urine bHCG)
- •Intolerance/allergy to local anesthetics
- •Weight <50 kg
- •Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- •Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- •Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course
研究组 & 干预措施
Mepivacaine Block Group
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
干预措施: Mepivacaine (Drug)
Mepivacaine Block Group
Injection of local anesthetic (mepivacaine) above and beside the femoral artery.
干预措施: Perifemoral Injection of Local Anesthetic (Procedure)
Saline Sham Group
Injection of salt water (saline) above and beside the femoral artery.
干预措施: Perifemoral Injection of Local Anesthetic (Procedure)
Saline Sham Group
Injection of salt water (saline) above and beside the femoral artery.
干预措施: Saline (Drug)
结局指标
主要结局
Number of Subjects Experiencing Tourniquet Hypertension
时间窗: Intraoperatively (~3 hours)
Measuring systolic blood pressure using a cuff, aim to keep \<30mmHg change from baseline
次要结局
- Pain Scores as Measured by the Numeric Rating Scale (NRS-11)(While in PACU (~1 hour))
- Amount of Opioid Pain Medications Used by Patient(Perioperative period (~4 hours))
- Amount of Esmolol Used Intraoperatively(Intraoperatively (~3 hours))
