Continuous Femoral Nerve Blockade and Readiness to Discharge Following Total Knee Arthroplasty
The Secret Recipe for Femoral Nerve Blockade After Total Knee Arthroplasty: A Randomized, Placebo-controlled, Double-blind Trial
Patients undergoing total knee arthroscopy (knee replacement) surgery usually receive a femoral nerve block as part of their anesthetic care. Some centers administer the block with a single shot of local anesthetic, which wears off several hours after surgery. Other centers administer the block with a single shot followed by continuous infusion of local anesthetic, typically for 2 to 5 days after surgery. The latter method, though good for pain control, may result in decreased mobility (while the anesthetic is still active), longer hospital stays, and greater risk of falls.
This study will see if using a lower concentration of local anesthetic for the continuous femoral nerve block or only the initial single-shot dose will result in increased mobility and shorter hospital stays.
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Ontario
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Toronto、Ontario、加拿大、M5T 2S8
- Toronto Western Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA physical status I-III
- 18-85 years of age, inclusive
- Able to communicate in English sufficiently to participate in the study
- Able to walk 30 metres without stopping prior to surgery
Exclusion Criteria:
- Intended discharge to in-patient rehabilitation facility
- Patient refusal of FNB or spinal anesthetic or sciatic nerve block
- Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, refusal)
- Significant peripheral neuropathy or neurological disorder affecting the lower extremity
- Contraindication to a component of multi-modal analgesia
- Pregnancy
- History of use of over 30mg oxycodone or equivalent per day (institutional threshold for acute pain service consultation pre-operatively)
- History of significant cognitive or psychiatric condition that may affect patient assessment
- Inability to provide informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：1
Initial Bolus dose of 0.2% ropivicaine followed by 0.2% ropivicaine infusion until day 2 post-op
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Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.2% ropivicaine at an infusion rate of 5mls/hr with patient controlled boluses of 5ml available every 30 mins, until 0600 on the morning of postoperative day 2
|
|
实验性的：2
Initial Bolus dose of 0.2% ropivicaine followed by 0.1% ropivicaine infusion until day 2 post-op
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Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.1% ropivicaine at an infusion rate of 10mls/hr with patient controlled boluses of 10mls available every 30 mins, until 0600 on the morning of postoperative day 2
|
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安慰剂比较：3
Initial Bolus dose of 0.375% ropivicaine followed by saline infusion until day 2 post-op
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Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Time to readiness to discharge from hospital
大体时间：Twice daily until discharge
|
Twice daily until discharge
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Quadriceps strength, knee flexion, walking distance, pain, patient satisfaction, opioid consumption, adverse events, incidence of falls, volume of local anesthetic administered, block success, discharge date, functional recovery
大体时间：Up to Month 6 post-operative
|
Up to Month 6 post-operative
|
合作者和调查者
调查人员
- 首席研究员：Richard Brull, MD、University Health Network, Toronto
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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