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Efficacy of IV Acetaminophen for Pain Management

2 de enero de 2019 actualizado por: Aultman Health Foundation

Efficacy of IV Acetaminophen for Pain Management Following Major Gynecologic Surgery: Effect on Opioid Rescue, Return of Bowel Function, Cost and Length of Hospital Stay.

The investigators' goal in this planned prospective, randomized, patient blinded study is to compare our standard of care as the control group to an experimental group in which patients receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8 doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will include amount of rescue opioids required, time to return of bowel function, length of hospital stay, and patient satisfaction. The hypothesis is that the addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of associated gastrointestinal side effects including nausea, vomiting, bloating, and constipation. The hope is that it will affect the final outcome of quicker return of bowel function, increased patient satisfaction, shortened hospital stay and prove to be an overall more effective postoperative pain management approach.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a patient-blinded prospective study in which patients that undergo major gynecologic surgery via an open abdominal approach will be randomized into two arms:

  1. Control Group: Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
  2. Experimental Group: Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Outcomes that will be analyzed include the amount of opioids used; time to return of bowel function designated as passage of flatus; time to first bowel movement if it occurs while inpatient; duration of hospital stay; and patient symptoms and satisfaction at the 24 and 48 hour marks as well as at time of discharge.

Tipo de estudio

Intervencionista

Inscripción (Actual)

68

Fase

  • Fase 4

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.

Ubicaciones de estudio

  • Estados Unidos
    • Ohio
      • Canton, Ohio, Estados Unidos, 44720
        • Aultman Health Foundation

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

18 años a 85 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.

Exclusion Criteria:

  • Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
  • Patients with baseline CrCl <30.
  • Patients that require intensive postoperative care and delayed extubation will typically require additional sedation which would impede adequate evaluation of the two study pain regimens as they are designed to be patient controlled.
  • Patients with complications unrelated to the pain regimens that prolong their stay would be excluded from the evaluation of hospital stay and cost effectiveness analyses. Examples would include but are not limited to pre-renal azotemia and acute renal failure; pneumonia; venous thromboembolism; or need for re-exploration laparotomy.
  • Allergy to acetaminophen would exclude those patients set to enter the experimental IV acetaminophen study arm. One exception would be if the allergy were trivial and related to route of administration such as mild nausea with oral acetaminophen.
  • Patients that undergo a bowel resection during surgery as it may adversely effect return of bowel function
  • Patients that have required regular opioid intake for the 7 days preceding surgery.
  • NSAIDs within 8 hours of surgery.
  • Chronic steroid use with the exception of low-dose inhaled steroid formulations.
  • Chronic alcohol or drug abuse.
  • Patients currently pregnant.
  • Patients unable to provide informed consent.
  • Age >85
  • Any physical, medical, and mental condition that would make participation in the study inadvisable.

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Experimental (Normal Saline)
Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Droga: Placebo
Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Otros nombres:
  • Placebo intravenoso
Comparador activo: Experimental (IV Acetaminophen)
Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
Droga: IV acetaminophen
IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Otros nombres:
  • Offirmev

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Opioid Rescue - 48 Hours
Periodo de tiempo: First 48 hours including pre-operative and intra-operative medications
Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine
First 48 hours including pre-operative and intra-operative medications

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Return of Bowel Function
Periodo de tiempo: Duration of hospital stay (up to 7 days).
Time to return of bowel function (passage of flatus) in hours
Duration of hospital stay (up to 7 days).
Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge
Periodo de tiempo: At 24 hours 48 hours, and discharge (up to 7 days)
Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
At 24 hours 48 hours, and discharge (up to 7 days)
Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge
Periodo de tiempo: At 24 hours, 48 Hours, and Discharge (up to 7 days)
Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
At 24 hours, 48 Hours, and Discharge (up to 7 days)
Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge
Periodo de tiempo: At 24 hours, 48 Hours, and Discharge (up to 7 days)
Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
At 24 hours, 48 Hours, and Discharge (up to 7 days)
Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge
Periodo de tiempo: At 24 hours, 48 Hours, and Discharge (up to 7 days)
Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
At 24 hours, 48 Hours, and Discharge (up to 7 days)
Length of Stay
Periodo de tiempo: Surgery to discharge
Mean length of post-operative stay in days
Surgery to discharge

Colaboradores e Investigadores

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

Patrocinador

Aultman Health Foundation

Investigadores

  • Investigador principal: Laura K Randolph, DO, MS, Aultman Health Foundation

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)

24 de diciembre de 2013

Finalización primaria (Actual)

4 de junio de 2014

Finalización del estudio (Actual)

4 de junio de 2014

Fechas de registro del estudio

Enviado por primera vez

2 de enero de 2014

Primero enviado que cumplió con los criterios de control de calidad

6 de enero de 2014

Publicado por primera vez (Estimar)

7 de enero de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de enero de 2019

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

2 de enero de 2019

Última verificación

1 de enero de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2013.08.22.F2

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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