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GENicular Nerve Block in KNEE Arthroplasty (GENKNEE)

2026년 8월 20일 업데이트: 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

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

70

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.

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.

다른 이름들:
  • GNB
  • Ultrasound-guided genicular nerve block
위약 비교기: 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.
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.
다른 이름들:
  • Saline nerve block

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Nummerical rating scale (NRS) pain
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
NRS Pain
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Tommy Frøseth Aae, MD, PhD, Department of orthopedic surgery, Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital Trust, Norway

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 17일

기본 완료 (추정된)

2028년 6월 1일

연구 완료 (추정된)

2029년 6월 1일

연구 등록 날짜

최초 제출

2026년 4월 29일

QC 기준을 충족하는 최초 제출

2026년 5월 11일

처음 게시됨 (실제)

2026년 5월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 20일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 962588
  • 2026/2578 (기타 식별자: Møre and Romsdal Hospital Trust)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

After publication and for 2 years

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .