A Randomized, Single Blind Study of the Efficacy and Safety of Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change in the Numeric Rating Pain Score
研究概览
简要总结
Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of three groups, each group will use a different approach using the ultrasound to guide the femoral nerve block as part of their treatment for controlling pain post-operatively.
详细描述
This will be a prospective, single-blinded, randomized study. The patients will be randomly assigned to one of three groups:
Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non stimulating catheter Group III - continuous femoral nerve block - stimulating catheter
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18- 90 years old
- •Scheduled for total knee arthroplasty
排除标准
- •Redo surgery on the same knee
- •Radicular pain in the same leg
- •Allergy to local anesthetics
- •Opioid habituation
- •Pregnancy
- •Contraindication to regional block
- •Inability to communicate with hospital staff or investigators.
- •Neuropathy of any etiology in the surgical extremity.
研究组 & 干预措施
Single shot femoral nerve block
A ultrasound probe will be used to identify the nerve, and correct needle placement.
干预措施: Femoral nerve block (Procedure)
Femoral nerve block non stimulating catheter
A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered off.
干预措施: Femoral nerve block (Procedure)
Femoral nerve block non stimulating catheter
A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered off.
干预措施: Femoral nerve block non stimulating catheter (Procedure)
Femoral nerve block stimulating catheter
A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered on.
干预措施: Femoral nerve block (Procedure)
Femoral nerve block stimulating catheter
A ultrasound probe will be used to identify the nerve, and correct needle placement. The catheter will be placed with the nerve stimulator powered on.
干预措施: Femoral nerve block stimulating catheter (Procedure)
结局指标
主要结局
Change in the Numeric Rating Pain Score
时间窗: Postoperative
At the conclusion of the surgery time 0, at 15, 30, and 45 minutes, at 1, 12, 24, 48 hours, and day 3, 7, 14, and 30 after the surgery.
次要结局
- Change in the ability to move the knee(Postoperative)
- Change in Supplemental pain medications(Postoperative)
研究者
Antony Tharian
MD
Chicago Anesthesia Pain Specialists