Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
研究概览
详细说明
Femoral nerve blocks are commonly used to provide postoperative analgesia for ACL surgery. The limitation of these blocks is the incomplete analgesia they provide of the knee joint subjecting the patient to posterior knee pain. As a result, some of these patients receive rescue sciatic blocks in the postoperative care unit to cover posterior knee pain. The sciatic block provides excellent analgesia for the posterior knee; however its blockade invariably affects other territories of the sciatic nerve such as the lower leg and foot. For ACL surgery, the loss of sensation and/or motor strength to this area is unnecessary and may make ambulation more difficult. The ability to ambulate with minimal assistance may be more important for a patient undergoing an outpatient surgery when compared to an inpatient surgery.
At the posterior knee, the sciatic nerve branches off into the tibial and common peroneal nerves which give rise to sensory fibers that innervate the posterior knee. We propose targeting these terminal fibers in the popliteal fossa by infiltrating local anesthetic between the distal femoral shaft and popliteal artery thereby providing posterior knee analgesia without affecting the lower leg.This application of this block has not been studied in patients having ACL surgery. A single interim analysis is scheduled after the data for 50 cases are available.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University Feinberg School of Medicine
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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:
- patients who are presenting for ACL reconstruction
- candidates for peripheral nerve blocks patients
- ASA 1-3
Exclusion Criteria:
- Patient refusal
- ASA Classification of 4 or higher
- Pre-existing neuropathy in the femoral or sciatic distribution
- Coagulopathy
- Infection at the site
- Non-English speaking or non-reading patients
- Chronic opioid use (>3months)
- Pregnancy
- Any other contra-indication to regional anesthesia
- Failed femoral nerve block
- Sciatic nerve block placed due to severe pain not managed by intravenous and oral agents.
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Study Drug
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000 (Study Drug)
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30mL of Bupivicaine 0.20% with epinephrine 1:300,000
其他名称:
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假比较器:Preservative free normal saline
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
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Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Opioid Consumption
大体时间:24 hours
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Opioid consumption (mg morphine equivalents)
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pain Score
大体时间:Pain Burden at 24hrs
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Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery.
Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain).
For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.
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Pain Burden at 24hrs
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Patient Satisfaction
大体时间:24hr
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Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
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24hr
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Quality of Recovery (QoR15)
大体时间:24hrs
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Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours.
Each question is followed by an 11-point numerical rating scale (0 = "none of the time" to 10 = "all of the time"; maximum score 150).
The higher the QoR15 total score, the worse the quality of recovery reported.
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24hrs
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合作者和调查者
调查人员
- 首席研究员:Rohit Rahangdale, M.D.、Northwestern University Feinberg School of Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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