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Efectividad del anestésico exparel administrado por el cirujano durante la cirugía de rodilla

24 de septiembre de 2026 actualizado por: The Cleveland Clinic

Un estudio piloto aleatorizado de un solo centro para evaluar la efectividad clínica de Exparel como un cirujano posteromedial intraarticular administrado (IPSA) en sujetos sometidos a artroplastia total de rodilla unilateral primaria

Intra-articular Posteromedial Surgeon Administered (IPSA) Block in this study describes a new type of medical procedure where a surgeon provides anesthetic medication directly into a specific area inside a knee joint to numb the pain during knee surgery. Intra-articular refers to inside of knee joint, posteromedial refers to the back and inner side of a knee joint, and surgeon administered means a surgeon is performing the procedure.

Patients You will be randomly assigned to one of these three treatment groups:

Group 1:

Patients in this group will receive IPSA block and Local Infiltration Analgesia (LIA).

IPSA block is a pain numbing medication given by surgeon and injected inside the back and inner side of the knee joint. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL.

Group 2 (Control):

Patients in this group will receive Adductor Canal Block (ACB) and Local Infiltration Analgesia (LIA). ACB is a pain numbing injection given by anesthesiologist near the adductor canal, a passage in the mid-thigh that contains nerves connecting the knee region. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL.

Group 3:

Patients in this group will receive Local Infiltration Analgesia (LIA). Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL.

The study will evaluate;

  • How effective the pain relief is after surgery.
  • How much extra pain medication you need.
  • Your satisfaction with pain management and recovery
  • Any side effects.

Descripción general del estudio

Descripción detallada

The study is a single-center, randomized, pilot study and will recruit up to 60 adult subjects undergoing unilateral total knee arthroplasty. Subjects will be randomized (1:1:1) to receive the treatments. The study participants will be followed for up to 90 days.

Information on analgesic use, pain, satisfaction with pain management will be obtained from patients. Participation begins when you sign the consent form. The treatment will begin on the day of the surgery. Follow up calls will be done 14 days and 90 days after surgery. Your involvement will last about 123 days.

Background and Rationale for the Study:

This study is being conducted to evaluate the clinical effectiveness of the Intra-articular Posteromedial Surgeon Administered (IPSA) block in subjects undergoing total knee arthroplasty (TKA). This study aims to demonstrate that a surgeon administered IPSA block can provide equivalent pain control to an anesthesiologist administered adductor canal block (ACB).

Method of Assigning Subjects to Treatment Randomization Scheme

Randomization Procedures Once a subject is identified as being qualified for the study in accordance with the eligibility criteria, the Investigator or designee will obtain a randomization assignment on the day of surgery. The subject will be considered randomized to the study once the study treatment is assigned.

Replacement of Subjects Subjects who withdraw from the study before the study treatment procedure may be replaced. Once a subject number is assigned, subject numbers will not be reused; subjects enrolled to replace those who withdraw will be assigned a unique subject number and randomized to treatment according to the procedures outlined above.

Subjects who are randomized but are withdrawn from the study before receiving the study drug may be replaced. Additionally, subjects may be replaced if insufficient and/or incomplete data are noted on safety or clinical outcomes.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Sanalkumar Krishnan, PhD
  • Número de teléfono: 216-445-7194
  • Correo electrónico: krishns11@ccf.org

Copia de seguridad de contactos de estudio

  • Nombre: Jaime Shuster, PhD
  • Número de teléfono: 216- 906-0508
  • Correo electrónico: shustej3@ccf.org

Ubicaciones de estudio

    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44113
        • Reclutamiento
        • Cleveland Clinic Lutheran Hospital
        • Investigador principal:
          • Matthew Deren, MD
        • Contacto:
          • Robert Molloy, MD
          • Número de teléfono: 216-445-5226
          • Correo electrónico: molloyr@ccf.org

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation:

1. Subjects ages 18 or older at screening 2. Indicated to undergo primary unilateral total knee arthroplasty under spinal anesthesia 3. Primary indication for TKA is degenerative osteoarthritis of the knee 4. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3 (see Appendix 6) 5. Able to provide informed consent, adhere to the study schedule, and complete all study assessments 6. Body Mass Index (BMI) ≥18 and <40 kg/m2

-

Exclusion Criteria:

  • Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study:

    1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
    2. Planned concurrent surgical procedure (e.g., bilateral TKA)
    3. Undergoing unicompartmental TKA or revision TKA
    4. Concurrent painful physical condition (e.g. arthritis, fibromyalgia, cancer) that may require analgesic treatment with NSAIDs or opioids in the post dosing period for pain that is not strictly related to the knee surgery and which, in the Investigator's opinion, may confound the post dosing assessments
    5. Inadequate sensory function below the knee as assessed by the Investigator
    6. History of contralateral TKA within 1 year
    7. Previous open knee surgery on the knee being considered for TKA. Prior arthroscopy is permitted
    8. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
    9. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
    10. Previous participation in an EXPAREL study
    11. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
    12. Currently pregnant, nursing, or planning to become pregnant during the study
    13. Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study.
    14. Any use of marijuana [including Tetrahydrocannabinol (THC) and Cannabidiol (CBD)] within 30 days prior to randomization, or planned use during the course of the study
    15. Chronic opioid use (average ≥30 oral morphine equivalents/day) within 30 days prior to surgery

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group 1

Patients in this group will receive IPSA block and Local Infiltration Analgesia (LIA).

Patients in this group will receive IPSA block and Local Infiltration Analgesia (LIA).

IPSA block is a pain numbing medication given by surgeon and injected inside the back and inner side of the knee joint. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL.

Comparador activo: Group 2-Control (Standard of Care)

Patients in this group will receive Adductor Canal Block (ACB) and Local Infiltration Analgesia (LIA).

ACB is a pain numbing injection given by anesthesiologist near the adductor canal, a passage in the mid-thigh that contains nerves connecting the knee region. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL.

Experimental: Group 3

Patients in this group will receive Local Infiltration Analgesia (LIA).

Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Questionnaires to assess the Pain levels of subjects enrolled in the study
Periodo de tiempo: 120 days

Patients answer survey questionnaires about knee pain and general health. Pain levels will be taken regularly at 8, 24, 48 and 72 hours after surgery at the healthcare facility. Follow up questionnaire on pain levels will be done at 14 days and 90 days post-surgery. Patients share how satisfied they are with pain management at 72 hours, 14 days and 90 days after surgery.

Subject's Reported Pain (Numeric Rating Scale) Pain intensity scores Subject will evaluate their pain in the operative knee using an 11-point Numeric Rating Scale (NRS), where 0=no pain and 10=worst possible pain.

120 days
Evaluate safety and any side effects
Periodo de tiempo: 120 days

Record any (i.e., adverse events [AEs]) related to the EXPAREL IPSA block for the enrolled subjects.

120 days
Medication usage
Periodo de tiempo: 120 days

Information about concomitant medication usage including opioids and analgesics

120 days
Subject Satisfaction Assessments
Periodo de tiempo: 120 days

Subject Satisfaction Assessments (Likert Scale) Subject Satisfaction with Pain Management

Overall satisfaction with your pain management. (Select one number only)

  1. Extremely dissatisfied
  2. Dissatisfied
  3. Neither satisfied nor dissatisfied
  4. Satisfied
  5. Extremely satisfied
120 days
Knee and general health survey
Periodo de tiempo: 120 days

Questionnaires on knee health and general health. KOOS JR : Knee function will be assessed by the KOOS-JR questionnaire Forgotten Joint Score - 12: Joint Awareness questionnaires The Veterans RAND 12 Item Health Survey (VR-12): Health related quality of life will be assessed by the VR-12

120 days
Body Mass Index
Periodo de tiempo: 120 days

weight and height measurements will be taken and calculated to report BMI in kg/m^2).

120 days

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Matthew Deren, MD, Associate Staff Orthopaedic Surgery

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de agosto de 2025

Finalización primaria (Estimado)

30 de marzo de 2027

Finalización del estudio (Estimado)

30 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

16 de abril de 2025

Primero enviado que cumplió con los criterios de control de calidad

23 de abril de 2025

Publicado por primera vez (Actual)

27 de abril de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 25-033

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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