An interventional study of Preoperative genicular nerve block (GNB) and Placebo nerve block in Osteoarthritis (OA) of the Knee, Total Knee Arthroplasty and Genicular Nerve Block, sponsored by Helse Møre og Romsdal HF. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Helse Møre og Romsdal HF · Not applicable, Interventional, and Treatment
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:
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:
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 70 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Helse Møre og Romsdal HF is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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
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
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
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
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
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
Steps per day
ActivPAL4Pro accelerator registration of mean steps per day measured 24/7 for a week.
Time frame: 1 week and 3 months
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)
Time frame: 1 week and 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
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