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Ecoguided Genicular Nerve Block

NCT06619080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-04-27

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Hospital Universitario Fundación Alcorcón

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2024-01-02
Completion
2024-11-02

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06619080 on ClinicalTrials.gov