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Saphenous Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty

2022年4月19日 更新者:Hospital for Special Surgery, New York

Saphenous (Adductor Canal) Nerve Block Versus Femoral Nerve Block for Total Knee Arthroplasty: A Novel Approach for Postoperative Analgesia

Currently, the regional anesthetic standard of care for total knee replacement surgery is combined spinal/epidural, with or without a femoral nerve block, or FNB. Lasting approximately 18 hours, the FNB works by numbing the femoral nerve (and its branches), which is the major nerve controlling the knee joint. The femoral nerve also provides movement and sensation. While this regional anesthetic technique offers significant postoperative pain relief, it is possible that it may cause muscle weakness and increase patients' recovery time. Hence there is a need for an alternative technique, one that may help minimize postoperative pain as effectively as the FNB, while not causing weakness of the quadriceps muscle.

The saphenous nerve, a branch of the femoral nerve, provides sensation to the knee. Thus it is hypothesized that 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 with the FNB, the quadriceps muscle itself will still be able to function.

Patients will be randomized to receive FNB or saphenous nerve block. Quadriceps strength will be tested using a dynamometer before surgery (baseline), 6-8 hours following anesthesia administration, and on postoperative days 1 and 2. It is hypothesized that patients who receive FNB will experience a 50% decrease in quadriceps strength compared to baseline.

研究概览

研究类型

介入性

注册 (实际的)

94

阶段

  • 不适用

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

    • New York
      • New York、New York、美国、10021
        • Hospital for Special Surgery

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 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All patients ages 18-90 undergoing primary unilateral total knee arthroplasty
  • Planned use of neuraxial anesthesia
  • Ability to follow study protocol
  • American Society of Anesthesiology (ASA) Class 1-3

Exclusion Criteria:

  • Contraindication to a spinal or epidural anesthetic
  • 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 a pre-existing neuropathy on the operative limb
  • Contraindication to a femoral nerve block or saphenous nerve block
  • Allergy to any of the study medications
  • Non-English speaking patients

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: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
实验性的:Experimental
Saphenous (Adductor Canal) Nerve Block
The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
其他名称:
  • Saphenous (Adductor Canal) Nerve Block
有源比较器:Control
Femoral Nerve Block
The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
其他名称:
  • 股神经阻滞

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
Quadriceps Muscle Strength
大体时间:48 hours following administration of anesthesia.
Measurements were made by a handheld dynamometer while patients perform isometric exercises. Results are presented in kilogram-force (kgF) units. One kgF is equal to 9.80665 N.
48 hours following administration of anesthesia.

次要结果测量

结果测量
措施说明
大体时间
Total Opioid Usage
大体时间:Postoperative day 4.
Opioid consumption data were collected and converted to oral morphine equivalents.
Postoperative day 4.
NRS Pain Scores at Rest
大体时间:Postoperative day 4.
Patients rated pain on a scale of 0-10, with 0 representing no pain and 10 representing worst pain.
Postoperative day 4.
Patient Satisfaction With the Nerve Block.
大体时间:24 hours following administration of anesthesia.
Patient satisfaction was measured on a 0-10 scale (0=not satisfied; 10=very satisfied).
24 hours following administration of anesthesia.
Incidence of Postoperative Complications.
大体时间:Postoperative day 4.
Postoperative day 4.
Total Length of Hospital Stay
大体时间:Total length of hospital stay
Total length of hospital stay

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:David H. Kim, MD、Hospital for Special Surgery, New York

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2011年3月1日

初级完成 (实际的)

2011年11月1日

研究完成 (实际的)

2011年11月1日

研究注册日期

首次提交

2011年4月8日

首先提交符合 QC 标准的

2011年4月11日

首次发布 (估计)

2011年4月12日

研究记录更新

最后更新发布 (实际的)

2022年5月11日

上次提交的符合 QC 标准的更新

2022年4月19日

最后验证

2022年4月1日

更多信息

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.

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