Ecoguided Genicular Nerve Block

NCT06619080 | Completed DMC

• 2 other identifiers: 22/1492022-003885-19
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee/Rehabilitation

Keywords

"Nerve Block"[MeSH Terms]; "Exercise"[MeSH Terms]; Ultrasound-guided infiltration; Genicular nerves

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain

  * 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 Outcomes (18)

• Mood Evaluation

  Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure

• Physical Examination

  Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure

• Functionality Improvement

  Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure

• Functionality improvement

  Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure

• Functionality Improvement

  Baseline, 4 weeks, 12 weeks, and 24 weeks post-procedure

Study Arms (3)

Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone).

ACTIVE COMPARATOR

Injection Doses: 2.5 mL of 0.5% bupivacaine + 20 mg of triamcinolone.

Drug: Genicular nerve block with bupivacaine and corticosteroids

Group 2: Block with 0.5% bupivacaine.

ACTIVE COMPARATOR

Injection Doses: 2.5 mL of 0.5% bupivacaine.

Drug: Genicular nerve block with bupivacaine

Group 3 (Control): Block with saline solution.

PLACEBO COMPARATOR

Injection Doses: 2.5 mL of saline solution.

Drug: Genicular nerve block with saline

Interventions

Genicular nerve block with bupivacaine and corticosteroids DRUG

\- 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.

Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone).

Genicular nerve block with bupivacaine DRUG

\- 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.

Group 2: Block with 0.5% bupivacaine.

Genicular nerve block with saline DRUG

\- 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.

Group 3 (Control): Block with saline solution.

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Fundación Alcorcón: lead

Study Sites (1)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (57)

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MeSH Terms

Conditions

Osteoarthritis

Interventions

Bupivacaine; Adrenal Cortex Hormones; Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Concealed Random Assignment: Participants will be assigned to one of three treatment groups using a computer-generated sequence. Opaque, sequentially numbered envelopes with treatment assignments will be opened after patient inclusion. Blinding of Participants: Participants will not know the specific injection content (bupivacaine with or without corticosteroids, or saline). They will only know they are receiving one of the study interventions. Blinding of Investigators: Investigators for initial evaluation and follow-up will not administer treatments. Independent personnel will prepare and administer treatments without evaluating outcomes. Blind Evaluations: Pain and functionality (VAS, KOOS, WOMAC, KUJALA) will be assessed by blinded investigators. Follow-up consultations will be handled by personnel unaware of treatment details. Documentation and Verification: Secure treatment assignment records will be accessible only to the data and safety monitoring committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Specialist in Physical Medicine and Rehabilitation

Model Details: Study Design Type of Study: Pilot randomized controlled experimental clinical trial. Number of Groups: Three parallel treatment arms. Intervention Groups: Group 1: Block with 0.5% bupivacaine and corticosteroid (triamcinolone). Group 2: Block with 0.5% bupivacaine. Group 3 (Control): Block with saline solution. Randomization Technique Description: Patient Position: Supine with knee extended. Ultrasound-Guided Localization: Use of ultrasound with Doppler to locate genicular nerves and associated arteries. Injection Points: Superior medial and lateral genicular nerves: Femoral condyle and junction with the femoral shaft. Inferior medial genicular nerve: Medial tibial-femoral joint line. Injection Doses: Group 1: 2.5 mL of 0.5% bupivacaine + 20 mg of triamcinolone. Group 2: 2.5 mL of 0.5% bupivacaine. Group 3: 2.5 mL of saline solution.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: October 1, 2024
• Study Start: April 26, 2023
• Primary Completion: January 2, 2024
• Study Completion: November 2, 2024
• Last Updated: April 27, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)