Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants Able to Hyperextend the Knee After Surgery
研究概览
简要总结
The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.
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
- 否
入选标准
- •English speaking
- •Between 18 and 75 years old
- •American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty
排除标准
- •ASA 4 or 5
- •Revision knee arthroplasty
- •Diagnosis of chronic pain
- •Daily chronic opioid use (over 3 months of continuous opioid use)
- •Inability to communicate pain scores or need for analgesia
- •Acute knee dislocation/fracture
- •Infection at the site of block placement
- •Age under 18 years old or greater than 75 years old
- •Pregnant women
- •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
iPACK Block Group
A nerve block technique using a numbing medication called ropivacaine.
干预措施: Ropivacaine (Drug)
iPACK Block Group
A nerve block technique using a numbing medication called ropivacaine.
干预措施: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block (Procedure)
Sham Group
The same nerve block technique as above, however using an inactive solution of salt water.
干预措施: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block (Procedure)
Sham Group
The same nerve block technique as above, however using an inactive solution of salt water.
干预措施: Saline (Drug)
结局指标
主要结局
Number of Participants Able to Hyperextend the Knee After Surgery
时间窗: Within 8 hours
Ability to hyperextend the knee after surgery
次要结局
- Ambulation as Measured by Distance Walked After Surgery(Post-operative Day 0)
- Pain as Measure by Numerical Rating Scale (NRS) 11(24 hours)
- Cumulative Opioid Consumption(24 hours)