Saphenous Nerve Block vs. Femoral Nerve Block for Total Knee Arthroplasty: A Comparative Effectiveness Study in Bilateral Total Knee Arthroplasty Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale Pain Score
研究概览
简要总结
Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural to provide long-lasting pain relief with or without a femoral nerve block (FNB). The femoral nerve block refers to a technique that your anesthesiologist can use to numb the thigh muscle for approximately 18 hours after surgery. While this technique offers significant pain relief, it is possible it may cause muscle weakness and increase patients' recovery times. Hence there is a need for an alterative anesthetic technique, one that may help minimize postoperative pain as effectively as a femoral nerve block, while not causing weakness of the thigh muscle.
The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized by "blocking" or anesthetizing the saphenous nerve with local anesthetic closer to where it branches off, the area around and below the knee will feel numb. Yet unlike the femoral nerve block, the thigh muscle itself will still be able to function.
For patients undergoing two total knee replacements at one time or bilateral total knee replacement, they will be randomly assigned to receive a femoral nerve block on one leg and a saphenous block on the other. Pain levels will be measured and thigh muscle strength will be tested using a dynamometer before surgery, 6-8 hours following anesthesia administration, and on postoperative days 1 and 2.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients ages 40-80 undergoing Bilateral Total Knee Replacement
- •Planned use of neuraxial anesthesia
- •Ability to follow study protocol
排除标准
- •Contraindication to a spinal or epidural anesthestic
- •Not a candidate for bilateral total knee replacement
- •Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
- •Hypersensitivity and/or allergy to local anesthetics
- •Intraoperative use of any volatile anesthetic
- •Patients with pre-existing neuropathy on the operative limb
- •Contraindication to femoral nerve block or saphenous nerve block
- •Allergy to any of the study medications
- •American Society of Anesthesiologists (ASA) Class 4-5
- •Non-English speaking patients
结局指标
主要结局
Visual Analogue Scale Pain Score
时间窗: Up to postoperative day 1
The primary outcome is the postoperative pain in each leg within the first 24 hours postoperatively. VAS pain scores could range from 0 to 10. Higher values represent a worse outcome.
次要结局
- Preoperative and Postoperative Thigh Muscle Strength in Both Legs(Up to postoperative day 2)
- Postoperative Complications(Up to postoperative day 2)
- Duration of Motor and Sensory Blockade(Up to postoperative day 2)
- Tracking Total Opioid Usage(Up to postoperative day 2)
- Rating the Success of the Nerve Blocks(Up to postoperative day 2)
- Patient Satisfaction With Nerve Blocks(Up to postoperative day 1)