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Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction

2017年3月8日 更新者:Rohit Rahangdale、Northwestern University

Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide analgesia for the front of the knee. Postoperatively, these patients will often report pain in the back of the knee. Local anesthetic infiltration of the posterior aspect of the knee results in blockade of the genicular nerves of the posterior knee. These nerves originate off of the tibial and common peroneal nerves and their blockade will result in improved posterior knee pain relief and may decrease narcotic consumption compared to patients who receive the same infiltration with normal saline.

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

介入性

注册 (实际的)

18

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University Feinberg School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. patients who are presenting for ACL reconstruction
  2. candidates for peripheral nerve blocks patients
  3. ASA 1-3

Exclusion Criteria:

  1. Patient refusal
  2. ASA Classification of 4 or higher
  3. Pre-existing neuropathy in the femoral or sciatic distribution
  4. Coagulopathy
  5. Infection at the site
  6. Non-English speaking or non-reading patients
  7. Chronic opioid use (>3months)
  8. Pregnancy
  9. Any other contra-indication to regional anesthesia
  10. Failed femoral nerve block
  11. Sciatic nerve block placed due to severe pain not managed by intravenous and oral agents.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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)
30mL of Bupivicaine 0.20% with epinephrine 1:300,000
其他名称:
  • 马卡因
假比较器:Preservative free normal saline
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
其他名称:
  • 0.9%氯化钠

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
Opioid consumption (mg morphine equivalents)
24 hours

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
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.
Pain Burden at 24hrs
Patient Satisfaction
大体时间:24hr
Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
24hr
Quality of Recovery (QoR15)
大体时间:24hrs
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.
24hrs

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2013年12月1日

初级完成 (实际的)

2015年11月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2013年12月6日

首先提交符合 QC 标准的

2013年12月10日

首次发布 (估计)

2013年12月11日

研究记录更新

最后更新发布 (实际的)

2017年4月19日

上次提交的符合 QC 标准的更新

2017年3月8日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Bupivacaine的临床试验

3
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