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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

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

70

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
手順：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.

他の名前：
  • GNB
  • Ultrasound-guided genicular nerve block
プラセボコンパレーター：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.
手順：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.
他の名前：
  • Saline nerve block

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Nummerical rating scale (NRS) pain
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
NRS Pain
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Helse Møre og Romsdal HF

協力者

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

捜査官

  • 主任研究者：Tommy Frøseth Aae, MD, PhD、Department of orthopedic surgery, Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital Trust, Norway

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月17日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2029年6月1日

試験登録日

最初に提出

2026年4月29日

QC基準を満たした最初の提出物

2026年5月11日

最初の投稿 (実際)

2026年5月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月21日

QC基準を満たした最後の更新が送信されました

2026年8月20日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 962588
  • 2026/2578 (その他の識別子：Møre and Romsdal Hospital Trust)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

After publication and for 2 years

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

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米国FDA規制機器製品の研究

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