- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04084288
Acupuncture for Low-Dose Opioid for TKA Replacement
Intraoperative Acupuncture for Low-Dose Opioid Total Knee Replacement: An Observational Prospective Cohort Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
New York
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New York, New York, Estados Unidos, 10021
- Hospital for Special Surgery
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- ASA of 1 or 2
- Age 18-70
- Undergoing primary total knee replacement
- Desire to attempt a low opioid or opioid free pathway
Exclusion Criteria:
- NonEnglish speaking
- Patients with the inability to understand or follow study protocol
- Opioid use in the last 6 weeks or chronic pain patient
- Cannot receive neuraxial anesthesia and/or peripheral nerve block
- Patients with contraindications to intraop protocol (e.g., patient cannot take acetaminophen or ketorolac due to liver or kidney disease)
- Patients with implanted cardiac device such as a pacemaker or AICD
- Active ear infection
- Nonnative ear, previous scarring or surgical manipulation of ear
- Patients with gauges or other deforming ear piercing (small nondeforming ear piercings are ok) present in ears
- Allergy to nickel
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Postoperative Acupuncture
Neuraxial anesthesia (spinal or combined spinal epidural (CSE) with up to 4cc mepivacaine 1.5%) and 2 blocks for postoperative pain (IPACK and adductor canal peripheral nerve blocks). Sedation will be provided. Tranexemic acid (TXA) will be dosed per surgeon request. A certified medical acupuncturist will perform ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed. If an epidural is placed, it may be redosed with lidocaine as needed (up to 100mg total) and will be removed prior to transfer to the recovery room. A periarticular injection (PAI) will be placed by the surgeon during the surgery (timing at the discretion of the surgeon) |
Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus).
Acupuncture needles will be left in place and stimulated for 60 min and then removed
Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Low-dose Opioid Regimen Adherence
Periodo de tiempo: postoperative day 0 to postoperative day 30
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The number of patients who maintain a low-dose opioid regimen (15 pills or less of 5mg oxycodone or 112.5 OME [oral morphine equivalents]) from postoperative day (POD) 0 to POD 30 throughout their Total Knee Replacement.
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postoperative day 0 to postoperative day 30
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Total Opioid Consumption
Periodo de tiempo: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
|
Postoperative opioid consumption measured in oral morphine equivalents (OME) at various timepoints
|
post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
|
Numerical Rating Scale (NRS) Pain Scores at Rest and With Movement
Periodo de tiempo: post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
|
Numerical Rating Scale (NRS) pain scores at rest and with movement.
NRS pain is measured from 0 to 10, with 0 being the no pain whatsoever and 10 being the worst pain imaginable.
|
post anesthesia care unit (PACU), postoperative day (POD) 1, POD7, POD14, POD30
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Duration of Neuraxial Anesthesia in Hours
Periodo de tiempo: postoperative day 1
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postoperative day 1
|
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Deviation From Prescribed Oral Pain Regimen
Periodo de tiempo: Postoperative day 30
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Tracking the number of patients that received different oral pain main medication, including the need for rescue medications by postoperative day 30
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Postoperative day 30
|
Number of Participants With Side Effects on POD1 and During the PACU Stay
Periodo de tiempo: PACU, Postoperative day 1
|
Incidence of nausea, vomiting, pruritus (itching), and constipation.
These are reported by the patient in the PACU and on postoperative day 1
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PACU, Postoperative day 1
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Postoperative Range of Motion
Periodo de tiempo: 6 weeks postoperative (surgeon office visit)
|
Postoperative range of motion measured at the 6 week surgeon office visit.
This is being measured by either the physician or their PA and is a score that is achieved by adding extension and flexion together.
It is measured in degrees.
(example: flexion: 118 + extension:1 = score: 119)
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6 weeks postoperative (surgeon office visit)
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Tourniquet Time
Periodo de tiempo: Intraoperatively
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Duration of time the tourniquet is inflated intraoperatively.
Measured in minutes
|
Intraoperatively
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephanie Cheng, MD, Hospital for Special Surgery, New York
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2019-1193
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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