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Summary
EudraCT Number:2022-003885-19
Sponsor's Protocol Code Number:NOT-APPLICABLE-HUFA
National Competent Authority:Spain - AEMPS
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2023-03-16
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2022-003885-19
A.3Full title of the trial
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
BLOQUEO ECOGUIADO DE NERVIOS GENICULARES DE RODILLA EN PACIENTES CON GONARTROSIS MEDIANTE ANESTÉSICO LOCAL O MEDIANTE LA COMBINACIÓN DE ANESTÉSICO LOCAL CON CORTICOIDE: ENSAYO CLÍNICO PILOTO CIEGO ALEATORIZADO CONTROLADO CON PLACEBO
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
TREATMENT OF KNEE PAIN IN PATIENTS WITH OSTEOARTHRITIS THROUGH THE COMBINATION OF LOCAL ANESTHETIC WITH CORTICOID OR ISOLATED LOCAL ANESTHETIC
TRATAMIENTO DEL DOLOR DE RODILLA EN PACIENTES CON ARTROSIS MEDIANTE LA COMBINACIÓN DE ANESTÉSICO LOCAL CON CORTICOIDE O ANESTÉSICO LOCAL AISLADO
A.3.2Name or abbreviated title of the trial where available
ECOGUIDED GENICULAR NERVE BLOCK. PLACEBO-CONTROLLED RANDOMIZED BLIND PILOT CLINICAL TRIAL
BLOQUEO DE NERVIOS GENICULARES ECOGUIADO. ESTUDIO PILOTO CIEGO ALEATORIZADO CONTROLADO CON PLACEBO
A.4.1Sponsor's protocol code numberNOT-APPLICABLE-HUFA
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Bupivacaine
D.2.1.1.2Name of the Marketing Authorisation holderBraun
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameBupivacaine
D.3.4Pharmaceutical form Injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPInfiltration
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name sodium chloride
D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product namesodium chloride
D.3.4Pharmaceutical form Injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPInfiltration
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 3
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name TRIGON DEPOT
D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameTRIGON DEPOT
D.3.4Pharmaceutical form Injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPInfiltration
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboInjection
D.8.4Route of administration of the placeboInfiltration
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
KNEE OSTEOARTHRITIS
E.1.1.1Medical condition in easily understood language
KNEE PAIN DUE TO OSTEOARTHRITIS
E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
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.
Comparar la eficacia del bloqueo de los nervios geniculares mediante anestésico local con y sin corticoide frente a grupo control para aliviar el dolor en pacientes con gonartrosis que realizan al mismo tiempo tratamiento mediante ejercicios de fisioterapia.
E.2.2Secondary objectives of the trial
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
Valorar efectos secundarios y/o interacciones a la técnica
Valorar la disminución de consumo de medicación analgésica
Valorar mejoría de la funcionalidad/calidad de vida del paciente
Valorar el estado anímico del paciente antes y después de la técnica
Valorar fisioterapia (ambulatoria vs hospitalaria) y adherencia al ejercicio
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
Anterior knee pain of patellofemoral origin and/or tibiofemoral compartment osteoarthritis
Pain assessment scale (VAS) ≥ 5
3 months of evolution
Dolor anterior de rodilla de origen patelofemoral y/o artrosis de compartimento femorotibial
Escala de valoración de dolor (EVA) ≥ 5
3 meses de evolución
E.4Principal 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
Menores de 18 años
Pacientes intervenidos mediante prótesis total o unicompartimental de rodilla
Viscosuplementación o inyección intraarticular con corticoides menos de 3 meses
Mujeres embarazadas o con sospecha de que lo pueden estar
Deterioro cognitivo o síntomas neuropsiquiátricos añadidos
No firmar consentimiento informado o revocación de éste
En estudio radiológico mediante la clasificación de Kellgren- Lawrence con valor <2
Pacientes con cardiopatía que precisen bloqueo mediante levobupivacaína
Incapacidad para escribir, hablar o leer en español
Patología tumoral o infecciosa activa
Artrosis secundaria a patología inflamatoria
E.5 End points
E.5.1Primary 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.
El bloqueo de los nervios geniculares mediante anestésico local en pacientes con gonartrosis dolorosa mejora el dolor, funcionalidad-calidad de vida del paciente y disminuye el consumo de analgésicos con igual o mejor resultado que el anestésico local asociado a corticoide.
E.5.1.1Timepoint(s) of evaluation of this end point
MARCH 2024
E.5.2Secondary end point(s)
MARCH 2024
E.5.2.1Timepoint(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.
Julio 2022: Planteamiento del estudio y comenzar con la revisión bibliográfica
Noviembre 2022: Registro como ensayo clínico y presentación a comité de ética e investigación clínica. (Pendiente de respuesta)
Enero 2023: Tras obtener aprobación por parte de CEIC se procederá a la recogida de datos de forma anónima y codificando a los participantes.
Agosto 2023: Fin de recogida de datos.
Marzo 2024: Análisis de los resultados obtenidos, y elaboración de las conclusiones.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo Yes
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial3
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
The objective would be to create a new coordination unit between the Rehabilitation and Orthopedic Surgery and Traumatology unit to create a rehabilitation program for patients who are going to undergo surgery using total or unicompartmental knee replacement.
El objetivo sería crear una nueva unidad de coordinación entre la unidad de Rehabilitación y Cirugía Ortopédica y Traumatología para crear un programa de rehabilitación en pacientes que vayan a ser sometidos a una intervención quirúrgica mediante prótesis total o unicompartimental de rodilla.
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 90
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 90
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state90
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
When THE participation ends, the participants will continue to receive the same follow-up and treatment from external Rehabilitation and Traumatology consultations. In other words, inclusion in this study does not exclude other medical-surgical treatments in the future.
Cuando acabe la participación, continuarán recibiendo el mismo seguimiento y el tratamiento por parte de consultas externas de Rehabilitación y Traumatología. Es decir, la inclusión a este estudio no excluye de otros tratamientos médico-quirúrgicos en el futuro.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2023-03-15
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2023-03-02
P. End of Trial
P.End of Trial StatusOngoing

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Condizioni mediche

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