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Osteoarthritis (OA) of the KneeGENKNEENCT07589127

GENicular Nerve Block in KNEE Arthroplasty

A study testing Preoperative genicular nerve block (GNB) in people with Osteoarthritis (OA) of the Knee and Total Knee Arthroplasty, run by Helse Møre og Romsdal HF at 1 site in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Preoperative genicular nerve block (GNB)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
1 siteNorway
Study dates
17 Jul 2026to 1 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Younger than 18 or older than 80 years
  • ASA physical status IV
  • Allergy to local anesthetics
  • Revision surgery
  • Chronic opioid use (> 3 months)
  • Coagulopathy
Show all 9Show fewer
  • Cognitive impairment
  • Inability to comply with study procedures
  • Patients scheduled for day care surgery.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Myrthle Slettvåg Hoel, Nurse contact

+47 71120000

myrthle.slettvag.hoel@helse-mr.no

Tommy Frøseth Aae, MD, PhD contact

+47 71120000

tommy.froseth.aae@helse-mr.no

Norway1 site, 1 recruiting
  • Nordmøre and Romsdal Hospital (SNR)

    Hjelset, Møre og Romsdal, 6412

    Myrthle Slettvåg Hoel, Studynurse, +47 71120000, Myrthle.Slettvag.Hoel@helse-mr.no

    Tommy Frøseth Aae, MD, PhD, +47 71120000, tommy.froseth.aae@helse-mr.no

    Recruiting

Other trials in Norway

About this study

Official title: 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:

Read more
  • 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
Read the detailed description

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.

Being tested
Preoperative genicular nerve block (GNB), Placebo nerve block
Keywords
Osteoarthritis, Knee, Knee osteoarthritis, Total knee arthroplasty, Genicular nerve block
Medical subject headings
Osteoarthritis, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Preoperative genicular nerve block (GNB)Procedure or surgery

    Also called GNB, Ultrasound-guided genicular nerve block

    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.

  • Placebo nerve blockProcedure or surgery

    Also called Saline 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.

Study groups in NCT07589127
Study groupRoleWhat they receive
Genicular nerve block (GNB)Active comparatorUltrasound-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.
Receives: Procedure: Preoperative genicular nerve block (GNB)
Placebo nerve blockPlacebo comparatorUltrasound-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.
Receives: Procedure: Placebo nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nummerical rating scale (NRS) pain

    Pain during ambulation measured using an 11-point NRS (0-10); reported as the difference in mean scores between the GNB and placebo groups.

    Measured: 24 hours

Secondary outcomes (5)
  1. NRS Pain

    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.

    Measured: 1 week, 1 month and 3 months

  2. Cumulative opioid consumption

    Self-reported oral opioid consumption collected via telephone or digital questionnaire and converted to cumulative oral morphine equivalents (MED) using standard conversion factors.

    Measured: 3 months

  3. EQ-5D-5L

    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' ).

    Measured: 3 months

  4. Steps per day

    ActivPAL4Pro accelerator registration of mean steps per day measured 24/7 for a week.

    Measured: 1 week and 3 months

  5. Forgotten Joint Score (FJS)

    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)

    Measured: 1 week and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start17 Jul 2026
  3. Primary completion1 Jun 2028 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, multiple-blind, placebo-controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07589127
Sponsor's protocol ID
962588
Other IDs
2026/2578
Acronym
GENKNEE
Status last verified
Aug 2026
First submitted
29 Apr 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 11491192
  • 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.

    PubMed 33678402
  • 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.

    PubMed 21479777
  • 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.

    PubMed 22000572
  • 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.

    PubMed 9699158
  • Tegner Y, Lysholm J. Rating systems in the evaluation of knee ligament injuries. Clin Orthop Relat Res. 1985 Sep;(198):43-9.

    PubMed 4028566
  • 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.

    PubMed 36220482
  • 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.

    PubMed 34261807
  • 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.

    PubMed 39143682
  • 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.

    PubMed 33035871
  • 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.

    PubMed 24939863
  • 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.

    PubMed 22221014
  • 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.

    PubMed 25111605
  • 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.

    PubMed 30237904
  • 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.

    PubMed 23392233

Questions about this trial

What is this clinical trial studying?

A study testing Preoperative genicular nerve block (GNB) in people with Osteoarthritis (OA) of the Knee and Total Knee Arthroplasty, run by Helse Møre og Romsdal HF at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Myrthle Slettvåg Hoel, Nurse (+47 71120000, myrthle.slettvag.hoel@helse-mr.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nummerical rating scale (NRS) pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07589127, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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