- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03728517
Narcotics Inpatient / Outpatient
Comparison of Inpatient Narcotics Use to Outpatient Prescription Narcotics Post-operatively
Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology.
The primary aim for this study are to better understand the factors that impact opioid use for pain management in gynecologic surgery patient after discharge. The second aim is to develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Managing pain in postoperative patients presents challenges in striking a balance between achieving adequate pain control and over-prescribing opioids that have the potential to contribute to the opioid epidemic. There are no clear guidelines informing postoperative opioid prescribing in obstetrics and gynecology. A recent study by As-Sanie et al. demonstrated that gynecologists at a large academic medical center prescribe twice the amount of opioids than the average patient uses after hysterectomy.1 Similarly, a study completed at Vanderbilt University Medical Center showed that obstetricians were overprescribing narcotics to patients after cesarean deliveries.2
In addition to rates of opioid prescribing, other factors affect postoperative opioid consumption, including individual patient measures of anxiety, depression, and self-reported pain scores prior to surgery. Preoperative Fibromyalgia symptom scores, STAIT state anxiety scores and NRS pain expectations are independent predictors for morphine consumption following hysterectomy.
There is a pressing need to better understand the factors that impact opioid use in women who undergo gynecologic surgery in order to mitigate the over-use of opioids for pain control upon discharge from the hospital.
Aims:
Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
- Is opioid consumption during the immediate postoperative recovery phase associated with consumption after discharge?
- Are variables that are known to be associated with opioid consumption, also associated with opioid consumption after discharge?
- Are there factors which we can use to predict opioid consumption in postoperative patients?
- Develop a model that incorporates individual patient baseline measures (e.g. anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University
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Indianapolis, Indiana, Estados Unidos, 46202
- Methodist Hospital
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Indianapolis, Indiana, Estados Unidos, 46202
- Eskenazi Health Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 18 years old or older
- Undergoing vaginal, laparoscopic or robotic gynecologic surgery requiring observation or inpatient stay overnight
- Agree to receiving contact from research staff for follow up
- Can provide two telephone numbers or a telephone number and email address
Exclusion Criteria:
- Unable to provide informed consent
- Age <18
- Intolerance/allergy to more than two narcotic medications
- Allergy/contraindication to non-steroidal anti-inflammatory drugs (NSAIDs)
- Has a diagnosed gynecologic malignancy other than Grade 1 endometrial cancer
- Pregnant
- Current opioid use on a regular basis (more than twice per week)
- Illicit drug-use within the past 30 days
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Subjects who undergo gynecologic surgery
Subjects who will undergo gynecologic surgery via vaginally, laparoscopic , or robotic who require observation or inpatient stay overnight.
This group will receive pain medication in the hospital and will also be discharged home with pain medication.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
Periodo de tiempo: 1 year
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Develop a model
Periodo de tiempo: 1 year
|
2. Develop a model that incorporates individual patient baseline measures (e.g.
anxiety, fibromyalgia score, inpatient narcotic consumption) to predict the amount of opioids needed following discharge.
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Insiyyah Y Patanwala, Indiana School of Medicine
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
Otros números de identificación del estudio
- 1805708779
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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