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GENicular Nerve Block in KNEE Arthroplasty (GENKNEE)

2026年8月20日 更新者：Helse Møre og Romsdal HF

GENicular Nerve Block in KNEE Arthroplasty - The GENKNEE Trial

The goal of this clinical trial is to learn whether a preoperative genicular nerve block (GNB) can reduce pain after knee replacement surgery in adults with knee osteoarthritis (OA) undergoing total knee arthroplasty (TKA). It will also assess whether this treatment can reduce opioid use and improve recovery.

The main questions it aims to answer are:

  • Does a preoperative GNB reduce pain during movement 24 hours after surgery compared with placebo?
  • Does it reduce opioid consumption and improve physical activity and functional outcomes after surgery?

Researchers will compare patients receiving a GNB to patients receiving a placebo injection to see if the nerve block improves postoperative pain and recovery.

Participants will:

  • Be randomly assigned to receive either a GNB or a placebo injection before surgery
  • Undergo standard knee replacement surgery and postoperative care
  • Report pain levels at regular intervals after surgery
  • Complete questionnaires on function, quality of life, and recovery
  • Wear an activity monitor to measure physical activity after surgery
  • Attend follow-up assessments at 1 week, 1 month, and 3 months

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Knee osteoarthritis (OA) is a common condition that causes pain, stiffness, and reduced mobility. For many patients, total knee arthroplasty (TKA) is an effective treatment to relieve pain and improve function. However, managing pain after surgery remains a major challenge. Poorly controlled pain can delay recovery, reduce mobility, and increase the need for opioid medications, which may have unwanted side effects.

This study investigates whether a specific pain treatment called a genicular nerve block (GNB) can improve pain control after knee replacement surgery. A GNB is a minimally invasive procedure where a local anesthetic is injected around small sensory nerves that supply the knee. While this technique is already used to treat chronic knee pain, its effect when given before surgery is not well established.

In this randomized, placebo-controlled clinical trial, patients undergoing primary TKA surgery will be assigned to receive either a GNB or a placebo injection before the operation. Neither the patients nor the healthcare providers involved in their care will know which treatment is given, ensuring unbiased results.

The main goal of the study is to determine whether patients who receive the nerve block experience less pain during movement in the first 24 hours after surgery compared with those who receive placebo. In addition, the study will evaluate whether the nerve block reduces the need for opioid pain medications, improves early physical activity, and leads to better recovery and function in the weeks and months after surgery.

Participants will be followed for three months after surgery. During this period, they will report pain levels, complete questionnaires about their function and quality of life, and wear an activity monitor to measure movement and recovery. The study will also assess possible side effects and complications, as well as the cost-effectiveness of the treatment.

By improving pain management and recovery after TKA, this study aims to contribute to better patient outcomes and more effective use of healthcare resources.

研究类型

介入性

注册 (估计的)

70

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。

学习联系方式

研究联系人备份

学习地点

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Symptomatic knee OA grade II-IV according to the Kellgren-Lawrence classification system scheduled for primary total knee arthroplasty
  • American Society of Anesthesiologists (ASA) Physical Status grade I-III
  • Able to provide written informed consent
  • Able to undergo surgery under spinal anesthesia

Exclusion Criteria:

  • Younger than 18 or older than 80 years
  • ASA physical status IV
  • Allergy to local anesthetics
  • Revision surgery
  • Chronic opioid use (> 3 months)
  • Coagulopathy
  • Cognitive impairment
  • Inability to comply with study procedures
  • Patients scheduled for day care surgery.

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：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：Genicular nerve block (GNB)
Ultrasound-guided GNB with 5 mL of 5 mg/mL ropivacaine at the superolateral genicular nerve (SLGN), superomedial genicular nerve (SMGN), and the inferomedial genicular nerve (IMGN) with a total volume of 15 mL.
程序：Preoperative genicular nerve block (GNB)

Participants randomized to the intervention group will receive a preoperative ultrasound-guided genicular nerve block prior to surgery. The procedure is performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance to identify anatomical landmarks.

A local anesthetic (ropivacaine 5 mg/mL) is injected at three sites targeting the sensory innervation of the knee joint: the superolateral, superomedial, and inferomedial genicular nerves. A volume of 5 mL is administered at each site, for a total of 15 mL. If the accompanying genicular artery is not visualized, the injection is performed at the corresponding bony landmark.

The intervention is administered once before surgery in addition to standard perioperative care, including spinal anesthesia, multimodal analgesia, and local infiltration analgesia during surgery.

其他名称：
  • GNB
  • Ultrasound-guided genicular nerve block
安慰剂比较：Placebo nerve block
Ultrasound-guided placebo nerve block using 5 mL of 0.9% normal saline at the superolateral genicular nerve (SLGN), superomedial genicular nerve (SMGN), and the inferomedial genicular nerve (IMGN) with a total volume of 15 mL.
程序：Placebo nerve block
Participants randomized to the placebo group will receive a preoperative ultrasound-guided placebo nerve block prior to surgery. The procedure is performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance to identify anatomical landmarks. 5 mL of 0.9% normal saline is injected at three sites targeting the sensory innervation of the knee joint: the superolateral, superomedial, and inferomedial genicular nerves. A volume of 5 mL is administered at each site, for a total of 15 mL. If the accompanying genicular artery is not visualized, the injection is performed at the corresponding bony landmark. The intervention is administered once before surgery in addition to standard perioperative care.
其他名称：
  • Saline nerve block

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
Nummerical rating scale (NRS) pain
大体时间：24 hours
Pain during ambulation measured using an 11-point NRS (0-10); reported as the difference in mean scores between the GNB and placebo groups.
24 hours

次要结果测量

结果测量
措施说明
大体时间
NRS Pain
大体时间：1 week, 1 month and 3 months
Pain during ambulation measured using an 11-point NRS (0-10) at predefined postoperative time points; reported as the difference in mean scores between the GNB and placebo groups.
1 week, 1 month and 3 months
Cumulative opioid consumption
大体时间：3 months
Self-reported oral opioid consumption collected via telephone or digital questionnaire and converted to cumulative oral morphine equivalents (MED) using standard conversion factors.
3 months
EQ-5D-5L
大体时间：3 months
A generic patient reported outcome measure measuring quality of life. The scale ranges from 100 ('the best imaginable health state') to 0 ('the worst imaginable health state' ).
3 months
Steps per day
大体时间：1 week and 3 months
ActivPAL4Pro accelerator registration of mean steps per day measured 24/7 for a week.
1 week and 3 months
Forgotten Joint Score (FJS)
大体时间：1 week and 3 months
FJS is a 12 item scale assessing the ability to forget the operated joint as artificial during activities of daily living. Ranges from 0 (bad) to 100 (excellent)
1 week and 3 months

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。

赞助

Helse Møre og Romsdal HF

合作者

Oslo University Hospital
St. Olavs Hospital
The Nordmøre and Romsdal Hospital Trust

调查人员

  • 首席研究员：Tommy Frøseth Aae, MD, PhD、Department of orthopedic surgery, Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital Trust, Norway

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 (实际的)

2026年7月17日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年4月29日

首先提交符合 QC 标准的

2026年5月11日

首次发布 (实际的)

2026年5月15日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 962588
  • 2026/2578 (其他标识符：Møre and Romsdal Hospital Trust)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data will be made available upon reasonable request following publication of the primary results. Data will be shared with researchers who provide a methodologically sound proposal, subject to a data access agreement, and in accordance with applicable laws and regulations.

IPD 共享时间框架

After publication and for 2 years

IPD 共享访问标准

Data will be shared in a secure manner, and access may require approval from relevant ethics or data protection authorities.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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