GENicular Nerve Block in KNEE Arthroplasty (GENKNEE)
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Myrthle Slettvåg Hoel, Nurse
- Número de teléfono: +47 71120000
- Correo electrónico: myrthle.slettvag.hoel@helse-mr.no
Copia de seguridad de contactos de estudio
- Nombre: Tommy Frøseth Aae, MD, PhD
- Número de teléfono: +47 71120000
- Correo electrónico: tommy.froseth.aae@helse-mr.no
Ubicaciones de estudio
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Møre og Romsdal
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Hjelset, Møre og Romsdal, Noruega, 6412
- Reclutamiento
- Nordmøre and Romsdal Hospital (SNR)
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Contacto:
- Tommy Frøseth Aae, MD, PhD
- Número de teléfono: +47 71120000
- Correo electrónico: tommy.froseth.aae@helse-mr.no
-
Contacto:
- Myrthle Slettvåg Hoel, Studynurse
- Número de teléfono: +47 71120000
- Correo electrónico: Myrthle.Slettvag.Hoel@helse-mr.no
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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.
Otros nombres:
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Comparador de placebos: 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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nummerical rating scale (NRS) pain
Periodo de tiempo: 24 hours
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Pain during ambulation measured using an 11-point NRS (0-10); reported as the difference in mean scores between the GNB and placebo groups.
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24 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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NRS Pain
Periodo de tiempo: 1 week, 1 month and 3 months
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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.
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1 week, 1 month and 3 months
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Cumulative opioid consumption
Periodo de tiempo: 3 months
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Self-reported oral opioid consumption collected via telephone or digital questionnaire and converted to cumulative oral morphine equivalents (MED) using standard conversion factors.
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3 months
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EQ-5D-5L
Periodo de tiempo: 3 months
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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' ).
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3 months
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Steps per day
Periodo de tiempo: 1 week and 3 months
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ActivPAL4Pro accelerator registration of mean steps per day measured 24/7 for a week.
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1 week and 3 months
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Forgotten Joint Score (FJS)
Periodo de tiempo: 1 week and 3 months
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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)
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1 week and 3 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tommy Frøseth Aae, MD, PhD, Department of orthopedic surgery, Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital Trust, Norway
Publicaciones y enlaces útiles
Publicaciones Generales
- Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
- Pabinger C, Lothaller H, Geissler A. Utilization rates of knee-arthroplasty in OECD countries. Osteoarthritis Cartilage. 2015 Oct;23(10):1664-73. doi: 10.1016/j.joca.2015.05.008. Epub 2015 May 29.
- Bauer MC, Pogatzki-Zahn EM, Zahn PK. Regional analgesia techniques for total knee replacement. Curr Opin Anaesthesiol. 2014 Oct;27(5):501-6. doi: 10.1097/ACO.0000000000000115.
- Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
- Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
- Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, Collins G, Kaufman J, Qorbani M, Moradi-Lakeh M, Woolf AD, Guillemin F, March L, Cross M. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020 Jun;79(6):819-828. doi: 10.1136/annrheumdis-2019-216515. Epub 2020 May 12.
- Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
- Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.
- Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
- Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
- Laigaard J, Pedersen C, Ronsbo TN, Mathiesen O, Karlsen APH. Minimal clinically important differences in randomised clinical trials on pain management after total hip and knee arthroplasty: a systematic review. Br J Anaesth. 2021 May;126(5):1029-1037. doi: 10.1016/j.bja.2021.01.021. Epub 2021 Mar 5.
- Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.
- Andersen LO, Kehlet H. Analgesic efficacy of local infiltration analgesia in hip and knee arthroplasty: a systematic review. Br J Anaesth. 2014 Sep;113(3):360-74. doi: 10.1093/bja/aeu155. Epub 2014 Jun 17.
- Suri P, Heagerty PJ, Korpak A, Jensen MP, Gold LS, Chan KCG, Timmons A, Friedly J, Jarvik JG, Baraff A. Improving Power and Accuracy in Randomized Controlled Trials of Pain Treatments by Accounting for Concurrent Analgesic Use. J Pain. 2023 Feb;24(2):332-344. doi: 10.1016/j.jpain.2022.09.017. Epub 2022 Oct 8.
- Vilchez-Cavazos F, Gamboa Alonso AA, Simental-Mendia M, Pena-Martinez VM, Acosta-Olivo CA, Villarreal-Villarreal GA. Genicular Nerve Block for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Clinical Trials. Clin J Pain. 2024 Oct 1;40(10):618-624. doi: 10.1097/AJP.0000000000001240.
- Layera S, Aliste J, Bravo D, Saadawi M, Salinas FV, Tran Q. Motor-sparing nerve blocks for total knee replacement: A scoping review. J Clin Anesth. 2021 Feb;68:110076. doi: 10.1016/j.jclinane.2020.110076. Epub 2020 Oct 6.
- Wylde V, Beswick A, Bruce J, Blom A, Howells N, Gooberman-Hill R. Chronic pain after total knee arthroplasty. EFORT Open Rev. 2018 Aug 16;3(8):461-470. doi: 10.1302/2058-5241.3.180004. eCollection 2018 Aug.
- GBD 2021 Gout Collaborators. Global, regional, and national burden of gout, 1990-2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2024 Aug;6(8):e507-e517. doi: 10.1016/S2665-9913(24)00117-6. Epub 2024 Jul 9.
- Inacio MCS, Graves SE, Pratt NL, Roughead EE, Nemes S. Increase in Total Joint Arthroplasty Projected from 2014 to 2046 in Australia: A Conservative Local Model With International Implications. Clin Orthop Relat Res. 2017 Aug;475(8):2130-2137. doi: 10.1007/s11999-017-5377-7. Epub 2017 May 9.
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Enviado por primera vez
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Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
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Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 962588
- 2026/2578 (Otro identificador: Møre and Romsdal Hospital Trust)
Plan de datos de participantes individuales (IPD)
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- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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