GENicular Nerve Block in KNEE Arthroplasty

NCT07589127 | Not Yet Recruiting

• 2 other identifiers: 9625882026/2578
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Osteoarthritis (OA) of the Knee; Genicular Nerve Block; Total Knee Arthroplasty

Keywords

Osteoarthritis; Knee; Knee osteoarthritis; Total knee arthroplasty; Genicular nerve block

Outcome Measures

Primary Outcomes (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.

  24 hours

Secondary Outcomes (5)

• NRS Pain

  1 week, 1 month and 3 months

• Cumulative opioid consumption

  3 months

• EQ-5D-5L

  3 months

• Steps per day

  1 week and 3 months

• Forgotten Joint Score (FJS)

  1 week and 3 months

Study Arms (2)

Genicular nerve block (GNB)

ACTIVE COMPARATOR

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.

Procedure: Preoperative genicular nerve block (GNB)

Placebo nerve block

PLACEBO COMPARATOR

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.

Procedure: Placebo nerve block

Interventions

Preoperative genicular nerve block (GNB) PROCEDURE

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.

Also known as: GNB, Ultrasound-guided genicular nerve block

Genicular nerve block (GNB)

Placebo nerve block PROCEDURE

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.

Also known as: Saline nerve block

Placebo nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Møre og Romsdal HF: lead
• The Nordmøre and Romsdal Hospital Trust: collaborator
• St. Olavs Hospital: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Nordmøre and Romsdal Hospital (SNR)

Hjelset, Møre og Romsdal, 6412, Norway

Location

Related Publications (20)

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MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Tommy Frøseth Aae, MD, PhD

  Department of orthopedic surgery, Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital Trust, Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A randomized, multiple-blind, placebo-controlled study

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication and for 2 years
• Access Criteria: Data will be shared in a secure manner, and access may require approval from relevant ethics or data protection authorities.

Locations

NO (1)