Health Trials

GENicular Nerve Block in KNEE Arthroplasty

ConditionsOsteoarthritis (OA) of the KneeTotal Knee ArthroplastyGenicular Nerve Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHelse Møre og Romsdal HF

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Younger than 18 or older than 80 years

ASA physical status IV

Allergy to local anesthetics

Revision surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative genicular nerve block (GNB)

    Procedure/Surgery

    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 block

    Procedure/Surgery

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Genicular nerve block (GNB)Active comparator 1 intervention
Group B: Placebo nerve blockPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
24 hours

Secondary outcomes

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.

Time frame
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.

Time frame
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' ).

Time frame
3 months
4

Steps per day

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

Time frame
1 week and 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helse Møre og Romsdal HF

Lead sponsor

The Nordmøre and Romsdal Hospital Trust

Collaborator

St. Olavs Hospital

Collaborator

Oslo University Hospital

Collaborator

Source ClinicalTrials.gov
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