- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02369211
Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)
Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Although IV acetaminophen has been studied in urologic surgery, it has not been studied specifically in prostatectomies, and therefore there are no outcomes or cost-effectiveness data currently available. In addition, the current trend is to perform prostatectomy with a robot-assisted laparoscopic technique to help minimize incision size, blood loss, postoperative pain, and speed up patient recovery. Current literature only includes the use of opioids in the perioperative setting for robot-assisted prostatectomy to treat pain, but only a small trial used oral acetaminophen as a measure for analgesia in RALP. In addition to the decreasing use of opioids in perioperative pain management, emphasis has been placed on reducing costs of healthcare. A major contributor to this issue is hospital length of stay (LOS) and there has been increased pressure on healthcare providers to decrease overall LOS. Several factors may contribute to hospital LOS, including hospital acquired infections, surgical recovery, wound care, other surgical and anesthesia-related complications, and importantly, inadequate pain control.
In this study we examine the impact of adding IV acetaminophen to the multimodal analgesic regimen for robotic-assisted laparoscopic prostatectomy (RALP). Our hypothesis is that the addition of IV acetaminophen can improve postoperative recovery time, inpatient LOS, postoperative pain scores, and opioid consumption.
This study specifically addresses pharmacoeconomics of IV acetaminophen. The goal is to understand its potential to improve hospital efficiency and patient outcomes. The study compares the impact of the addition of IV acetaminophen versus a placebo on postoperative anesthesia care unit recovery times, inpatient LOS, postoperative pain scores, consumption of opiates as rescue agents and side effects in patients undergoing RALP.
The study is a 2-arm, double-blind, randomized, placebo controlled trial comparing IV acetaminophen to a control (IV placebo). All patients in this study were scheduled to undergo RALP.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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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:
- Patients undergoing robotic-assisted laparoscopic prostatectomy
- ≥18 years old males
- American Society of Anesthesiologists class 1-4
Exclusion Criteria:
- Chronic opiate use
- Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)
- Allergy/hypersensitivity to acetaminophen
- Patients with baseline dementia
- Chronic diathesis
- Chronic kidney disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Intravenous acetaminophen
Patient receives 1g intravenous acetaminophen after the incision
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The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.
Otros nombres:
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Comparador de placebos: Placebo
Patient receives saline injection instead of the study drug
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The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Post Anesthesia Care Unit Length of Stay
Periodo de tiempo: approximately 30-240 min
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The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.
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approximately 30-240 min
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Hospital Length of Stay
Periodo de tiempo: 1-3 days
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This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.
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1-3 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain Score
Periodo de tiempo: 0-24 hours after surgery
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Pain scores were collected using the Visual Analog Scale. The scale range is 0 (no pain) to 10 (most pain). Mean pain score over first 24 hours postoperatively was collected. |
0-24 hours after surgery
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Opioid Use
Periodo de tiempo: 0-24 hours
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A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital
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0-24 hours
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Richard Urman, MD, Brigham and Women's Hospital
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 (Estimar)
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
- 2014P002749
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
Ensayos clínicos sobre Acetaminophen (Ofirmev)
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Janssen Korea, Ltd., KoreaTerminado
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University of California, DavisTerminadoAcetaminofén en dosis orales preoperatorias modificadas versus acetaminofén intravenoso (MODIV-APAP)Amigdalectomía | AdenoidectomíaEstados Unidos
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University of PittsburghTerminadoDolorEstados Unidos
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Beth Israel Deaconess Medical CenterNational Institute on Aging (NIA)ReclutamientoEnfermedad de la arteria coronaria | Delirio | Delirio en la vejezEstados Unidos
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Richmond University Medical CenterDesconocidoFiebre | Estrés oxidativoEstados Unidos
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MallinckrodtTerminado
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Saint Francis CareTerminadoDolor | ObesidadEstados Unidos
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The University of Texas Health Science Center,...MallinckrodtTerminado
-
MallinckrodtTerminado
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Stanford UniversityMayo Clinic; University of British Columbia; Albert Einstein College of Medicine; Vanderbilt University Medical Center y otros colaboradoresTerminadoDolor | Dolor Postoperatorio | Sinusitis | Uso de opioides | Abuso de opioides | Uso de narcóticos | Enfermedad OtorrinolaringológicaEstados Unidos, Canadá