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TREATMENT OF KNEE PAIN IN PATIENTS WITH OSTEOARTHRITIS THROUGH THE COMBINATION OF LOCAL ANESTHETIC WITH CORTICOID OR ISOLATED LOCAL ANESTHETIC

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 - ECOGUIDED GENICULAR NERVE BLOCK. PLACEBO-CONTROLLED RANDOMIZED BLIND PILOT CLINICAL TRIAL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2022-003885-19-ES
Enrollment
90
Registered
2023-03-16
Start date
2023-03-15
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

KNEE OSTEOARTHRITIS

Interventions

Trade Name: Bupivacaine Product Name: Bupivacaine Pharmaceutical Form: Injection Trade Name: sodium chloride Product Name: sodium chloride Pharmaceutical Form: Injection Pharmaceutical form of the pl

Sponsors

NO-COMERCIAL
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Anterior knee pain of patellofemoral origin and/or tibiofemoral compartment osteoarthritis Pain assessment scale (VAS) = 5 3 months of evolution Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90

Exclusion criteria

Exclusion criteria: Under 18 years Patients who underwent total or unicompartmental knee replacement Viscosupplementation or intra-articular injection with corticosteroids for less than 3 months Pregnant women or women suspected of being pregnant Cognitive impairment or added neuropsychiatric symptoms Failure to sign informed consent or revocation of it In a radiological study using the Kellgren-Lawrence classification with a value <2 Patients with heart disease who require blockade with levobupivacaine Inability to write, speak or read in Spanish Active tumor or infectious pathology Osteoarthritis secondary to inflammatory pathology

Design outcomes

Primary

MeasureTime frame
Main Objective: To compare the efficacy of genicular nerve block using local anesthetic with and without corticosteroids versus a control group to relieve pain in patients with gonarthrosis who are simultaneously treated with physiotherapy exercises.;Secondary Objective: Evaluate secondary effects and/or interactions to the technique Assess the decrease in the consumption of analgesic medication Evaluate improvement of the functionality/quality of life of the patient Assess the patient's state of mind before and after the technique Assess physiotherapy (outpatient vs. hospital) and adherence to exercise;Primary end point(s): Genicular nerve block with local anesthetic in patients with painful gonarthrosis improves pain, functionality-quality of life of the patient and decreases the consumption of analgesics with equal or better results than local anesthetic associated with corticosteroids.;Timepoint(s) of evaluation of this end point: MARCH 2024

Secondary

MeasureTime frame
Secondary end point(s): MARCH 2024;Timepoint(s) of evaluation of this end point: July 2022: Study approach and start with the bibliographic review November 2022: Registration as a clinical trial and presentation to the ethics and clinical research committee. (Answer pending) January 2023: After obtaining approval from the CEIC, the data will be collected anonymously and coding the participants. August 2023: End of data collection. March 2024: Analysis of the results obtained, and elaboration of the conclusions.

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026