Ecoguided Genicular Nerve Block

April 24, 2025 updated by: Claudia de la Fuente Escudero, Hospital Universitario Fundación Alcorcón

Ecoguided Genicular Nerve Block in Patients With Knee Osteoarthritis by Local Anesthetic or by Combination of Local Anesthetic and Corticoid: Placebo-Controlled Randomized Blind Clinical Trial

Osteoarthritis is a pathology with high prevalence in the world and is increasing due to sedentary lifestyles. Recent researches that claim for conservative treatment have shown the utility of genicular nerve blocks for relief of chronic knee pain.

Likewise, the ultrasound-guided technique has been more popular among professionals in recent years due to its low cost and safety.

This pilot study tries to evaluate if the infiltration of local anesthetic could avoid the use of corticosteroids with the secondary effects that they entail, therefore, it is carried out with the intention of estimating the size of the effect and the use of the variable response for later carrying out a clinical trial.

For this, we propose the comparative analysis of three randomized groups of patients (n=90), where all of them will perform a quadriceps strengthening exercise at home. Moreover, we will assess the reduction of pain through the visual analog scale (VAS) after the genicular nerve block with ultrasound-guided infiltration. Group 1 (n=30) will be infiltrated with local anesthetic and steroid, group 2 (n=30) with local anesthetic and group 3 (n=30), as a control group, will receive physiological saline. We will also record demographic data, functionality and mood using validated scales.

Study Overview

Status

Completed

Conditions

Osteoarthritis, Knee/Rehabilitation

Intervention / Treatment

Detailed Description

Osteoarthritis affects approximately 302 million people worldwide, with the knee, hip, and hands being the most commonly affected areas. Knee osteoarthritis is highly prevalent and increasing in the region due to aging, obesity, and the progressive sedentary lifestyle of the population. According to recent epidemiological studies, it has a prevalence of 29.3% in the Spanish population.

Currently, multiple treatment options are available, ranging from conservative measures to surgical procedures. Within conservative treatment, various tools benefit patients and may even avoid the need for surgery. These non-surgical options include patient education, weight control, physical exercise, orthotics, oral analgesics, topical anti-inflammatories, and interventional procedures. However, there are no prior studies demonstrating the advantages of one over another, and many do not follow up beyond three months.

When conservative treatment is ineffective, surgical intervention is usually considered. Therapeutic options include knee arthroscopy, high tibial osteotomy, total knee replacement, and unicompartmental knee replacement in patients without lateral compartment disease.

Traditionally, rest and caution in exercise were recommended for knee osteoarthritis pain. However, this paradigm has been strongly rejected. One of the current first-line treatments for knee osteoarthritis is physical exercise, with quadriceps strengthening being the most indicated. Most patients seek recommendations on what type of exercise to perform, including the duration, intensity, and frequency for better adherence. No exercise has been shown to be superior to another, with the most studied being yoga and tai chi exercises.

Despite the well-documented benefits of exercise for this condition, one emerging procedure for pain management is the genicular nerve block. This treatment option can facilitate progress in the exercise program. It is also indicated for patients who have previously had successful genicular block, those who do not wish to undergo surgery, those not eligible for surgery, or even post-surgical patients for better pain control.

The term "genicular nerves" refers to a group of nerves responsible for the sensory innervation of the knee joint capsule and the internal and external ligaments. The superior and inferior medial genicular nerves are sensory branches of the tibial nerve, whereas the superior and inferior lateral genicular nerves are branches of the common peroneal nerve. These nerves are named after the arteries they accompany, which are located using ultrasound during the procedure.

Genicular nerve block is a simple technique that significantly reduces opioid consumption in patients undergoing total knee arthroplasty within the first 24 hours. It also provides temporary relief that allows progression in the rehabilitation program through a structured exercise regimen. This technique involves injecting medication into the genicular nerves, locating the genicular artery using Doppler ultrasound. Various cadaveric studies have investigated the anatomical distribution of the descending genicular artery and the nerves accompanying its branches.

Some authors suggest that up to 10 points may need to be blocked for complete coverage. However, this is not feasible in routine clinical practice. Most studies target three sensory nerves of the knee: the superior lateral genicular nerve, the superior medial genicular nerve, and the inferior medial genicular nerve. In most studies, 2 to 3 ml of local anesthetic is administered per point. It has been shown that 0.5 ml of injected fluid spreads within the tissue over an area of 6 cm², likely covering more nerve targets with 2 ml. Typically, the procedure involves infiltrating local anesthetic (lidocaine, bupivacaine, ropivacaine, levobupivacaine) and 20 mg of corticosteroid (triamcinolone).

In this study, bupivacaine is chosen as the local anesthetic, as it inhibits prostaglandin production by binding to the E2 receptor, providing an anti-inflammatory effect. It is a lipophilic amide-type anesthetic with 100% bioavailability and a longer duration than other local anesthetics. Additionally, it produces a more significant blockade of sensory and sympathetic nerve fibers than motor fibers, differentiating it from other local anesthetics.

Recent guidelines for the treatment of knee osteoarthritis highlight the recommendation of intra-articular corticosteroid injections. However, several studies mention that systemic and local corticosteroid effects can cause adverse effects such as skin atrophy, hypertension, insulin resistance, decreased bone mineralization, and septic arthritis, among others. Nonetheless, these effects have not demonstrated a direct relationship with pain, functionality, or radiological changes.

The clinical benefit of corticosteroid administration compared to local anesthesia alone remains unclear. Given the potential adverse effects, corticosteroids may not be suitable as adjuvants. Therefore, genicular nerve block using local anesthetic alone proves to be a promising technique, avoiding the use of corticosteroids and not being an intra-articular procedure.

A study is proposed at a tertiary hospital in the Community of Madrid (Hospital Universitario Fundación Alcorcón). Considering the absence of previous studies that evaluate and quantify the three described treatment options, this study aims to address this objective through a pilot experimental randomized controlled trial. All patients will receive guidelines for an exercise program, and the outcomes of adding genicular nerve block with and without corticosteroid will be assessed. This unprecedented study could identify the optimal treatment for this prevalent and debilitating condition in a significant portion of the population. Additionally, it will help optimize resource allocation for these patients by identifying the best therapeutic target, thus avoiding unnecessary resource consumption

Study Type

Interventional

Enrollment (Actual)

102

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- Madrid
  - Alcorcón, Madrid, Spain, 28922
    - Hospital Universitario Fundacion Alcorcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Age over 18 years
Anterior knee pain of patellofemoral origin and/or femorotibial compartment osteoarthritis with no previous response to pharmacological treatment (oral and/or topical)
Pain duration of 3 months
Pain assessment scale (Numerical Rating Scale) ≥ 5
Radiological study with Kellgren-Lawrence classification > 2

Exclusion Criteria:

Allergy to the active ingredients and excipients of: bupivacaine, triamcinolone, or saline solution
Patients who have undergone total or unicompartmental knee replacement surgery
Viscosupplementation or intra-articular corticosteroid injection within the last 3 months
Pregnant women or those suspected of being pregnant
Cognitive impairment or additional neuropsychiatric symptoms
Failure to sign informed consent or revocation of it
Patients with heart disease requiring blockade with levobupivacaine
Inability to write, speak, or read in Spanish
Active tumoral or infectious pathology
Osteoarthritis secondary to inflammatory pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone). Injection Doses: 2.5 mL of 0.5% bupivacaine + 20 mg of triamcinolone.	Drug: Genicular nerve block with bupivacaine and corticosteroids - GROUP 1:Genicular Nerve Block with Bupivacaine and Corticosteroids: 2.5 mL at three genicular nerve points. All injections are ultrasound-guided and administered once. The primary outcome is pain reduction, measured using NRS, KOOS, WOMAC, and KUJALA scales at 4, 12, and 24 weeks post-injection. Follow-up includes phone and in-person consultations to monitor pain, functionality, and adverse effects.
Active Comparator: Group 2: Block with 0.5% bupivacaine. Injection Doses: 2.5 mL of 0.5% bupivacaine.	Drug: Genicular nerve block with bupivacaine - GROUP 2: Genicular Nerve Block with Bupivacaine: 2.5 mL at three genicular nerve points. All injections are ultrasound-guided and administered once. The primary outcome is pain reduction, measured using NRS, KOOS, WOMAC, and KUJALA scales at 4, 12, and 24 weeks post-injection. Follow-up includes phone and in-person consultations to monitor pain, functionality, and adverse effects.
Placebo Comparator: Group 3 (Control): Block with saline solution. Injection Doses: 2.5 mL of saline solution.	Drug: Genicular nerve block with saline - GROUP 3: Genicular Nerve Block with Saline: 2.5 mL at three genicular nerve points. All injections are ultrasound-guided and administered once. The primary outcome is pain reduction, measured using NRS, KOOS, WOMAC, and KUJALA scales at 4, 12, and 24 weeks post-injection. Follow-up includes phone and in-person consultations to monitor pain, functionality, and adverse effects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in Pain Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure	Measurement Tool: Numeric Rating Scale (NRS) Minimum Value: 0 Maximum Value: 10 Interpretation: Higher scores indicate worse pain.	Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood Evaluation Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure	EVEA (Emotional State Evaluation Scale) [Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure] Minimum Value: 0 Maximum Value: 100 Interpretation: Higher scores indicate a worse emotional state	Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Physical Examination Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure	Degrees of Knee Flexion and Extension [Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure] Measurement Tool: Goniometer Minimum Value: 0 degrees (full extension) Maximum Value: 140 degrees (full flexion) Interpretation: Higher values indicate greater knee flexion. Description: Physical examination to assess changes in the range of motion of the knee	Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality Improvement Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure	- KOOS (Knee Injury and Osteoarthritis Outcome Score) [Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure] Minimum Value: 0 Maximum Value: 100 Interpretation: Higher scores indicate better knee function.	Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality improvement Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure	- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index Score) Minimum Value: 0 Maximum Value: 96 Interpretation: Lower scores indicate better knee function.	Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Functionality Improvement Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure	KUJALA Scale: Minimum Value: 0 Maximum Value: 100 Interpretation: Higher scores indicate better knee function	Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure
Incidence of Adverse Events Time Frame: Through study completion, an average of 1 year	Monitoring and documentation of any adverse events to evaluate the safety of the interventions.	Through study completion, an average of 1 year
Demographic and clinical variables Time Frame: Baseline	2. Sex [Time Frame: Baseline] o Measurement: Gender (Male/Female)	Baseline
Demographic and Clinical Variables Time Frame: Baseline	1. Age [Time Frame: Baseline] o Measurement: Age in years	Baseline
Demographic and clinical variables Time Frame: Baseline	3. Hypertension [Time Frame: Baseline] o Measurement: Presence of hypertension (Yes/No)	Baseline
Demographic and clinical variables Time Frame: Baseline	Diabetes Mellitus [Time Frame: Baseline] o Measurement: Presence of diabetes mellitus (Yes/No)	Baseline
Demographic and clinical variables Time Frame: Baseline	Body Mass Index (BMI) [Time Frame: Baseline] Measurement: BMI in kg/m² Minimum Value: Variable Maximum Value: Variable Interpretation: Higher values indicate higher body weight relative to height.	Baseline
Demographic and clinical variables Time Frame: Baseline	Anticoagulation Status [Time Frame: Baseline] o Measurement: Use of anticoagulants (Yes/No)	Baseline
Demographic and clinical variables Time Frame: Baseline	Laterality (Left or Right Knee) [Time Frame: Baseline] o Measurement: Knee affected (Left/Right)	Baseline
Demographic and clinical variables Time Frame: Baseline	Duration of Symptoms [Time Frame: Baseline] o Measurement: Duration of knee pain in months	Baseline
Demographic and clinical variables Time Frame: Baseline	Previous Intra-Articular Injections [Time Frame: Baseline] o Measurement: History of previous injections (Yes/No)	Baseline
Analgesic Medication Use Time Frame: Through study completion, an average of 1 year	Description: Analysis of the reduction in the use of analgesic medications post-procedure	Through study completion, an average of 1 year
Demographic and clinical variables Time Frame: Baseline	10. Use of Assistive Walking Devices Measurement: Yes/No	Baseline
Analgesic Medication Use Time Frame: Through study completion, an average of 1 year	o Measurement: Type of analgesic medication consumed	Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Fundación Alcorcón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2023

Primary Completion (Actual)

January 2, 2024

Study Completion (Actual)

November 2, 2024

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

22/149
2022-003885-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Plan Description: Individual participant data (IPD) collected in this study will not be shared. The reasons for this decision include:

Privacy Concerns: Protecting participant confidentiality is paramount. Sharing IPD could potentially compromise participant privacy
Proprietary Information: The data collected includes proprietary information that cannot be disclosed due to legal or contractual reasons
Data Quality and Integrity: To maintain the accuracy and integrity of the data, sharing IPD might lead to misuse or misinterpretation
Institutional Policies: Institutional policies restrict the sharing of data to comply with ethical and regulatory standards
Resource Limitations: The study team lacks the resources to manage and facilitate IPD sharing effectively

Access Criteria: As IPD will not be shared, there are no access criteria.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Ecoguided Genicular Nerve Block