Femoral Peri-arterial Local Anesthetic Injection Via Peri-arterial Perineural Catheter Reverses Tourniquet Associated Ischemic Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in tourniquet hypertension as measured by systolic blood pressure
研究概览
简要总结
The goal of this prospective randomized double-blind study is to determine if an ultrasound guided peri-arterial injection of local anesthetic (LA) superomedially the femoral artery via peripheral nerve catheter reverses ischemic hypertension associated with prolonged lower extremity tourniquet time.
详细描述
This is a research study to find out if injection of numbing medication by the large artery going down your leg will improve high blood pressure caused by the tourniquet.
Depending on whether you enroll in this study, you may receive an injection of local anesthetic (numbing medication) or saline (salt water) by your femoral artery (the large artery going down your leg). This is to see how this injection impacts your blood pressure during surgery as the surgeons use a tourniquet (device that squeezes your leg) to help decrease the bleeding during surgery. Oftentimes the tourniquet causes your blood pressure to go up, but the numbing medication may help return your blood pressure close to its normal level. The rest of your anesthesia care, including other nerve blocks and general anesthetic, will be the same as it would be without participating in the study. You will be enrolled in this study for 24 hours.
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
Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.
干预措施: Mepivacaine (Drug)
Mepivacaine Block Group
Infiltration of local anesthetic (mepivacaine) above and beside the femoral artery through a perineural catheter.
干预措施: Perifemoral Injection of Local Anesthetic (Procedure)
Saline Sham Group
Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.
干预措施: Saline (Drug)
Saline Sham Group
Infiltration of salt water (saline) above and beside the femoral artery through a perineural catheter.
干预措施: Perifemoral Injection of Local Anesthetic (Procedure)
结局指标
主要结局
Change in tourniquet hypertension as measured by systolic blood pressure
时间窗: From time of injection to 30 minutes after injection
Infiltrating study drug to reverse intraoperative tourniquet hypertension
次要结局
- Opioid consumption(Perioperative start until 2 hours after admission to PACU)
- Pain Scores (NRS11)(Perioperative start until 2 hours after admission to PACU)
- Quadriceps motor function(1 hour after extubation)