- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Understand the factors that impact opioid use for pain management in gynecologic surgery patients after discharge.
Prazo: 1 year
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1 year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Develop a model
Prazo: 1 year
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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.
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Insiyyah Y Patanwala, Indiana School of Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 1805708779
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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