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Prevalence and Predictors of Prolonged Post-surgical Opioid Use: a Prospective Observational Cohort Study

9 de mayo de 2017 actualizado por: Natasha Stark, University of Notre Dame Australia
Post-surgical opioid prescribing intended for the short-term management of acute pain may lead to long-term opioid use, and its associated harms. This study was undertaken to determine the prevalence of prolonged post-surgical opioid use, and patient-related factors associated with prolonged post-surgical opioid use.

Descripción general del estudio

Descripción detallada

There are growing concerns that surgery is a risk factor for chronic opioid use. Existing studies suggest that post-surgical opioid prescribing intended for the short-term management of acute pain may result in unintended long-term opioid use for a small, but meaningful number of patients.

Increasing numbers of patients are discharged from hospital post-surgery with opioids for the management of their acute post-surgical pain. Opioids have proven efficacy for the management of acute post-surgical pain, but can cause significant harm when used long-term for non-cancer pain. Evidence suggests that post-surgical opioid use continues in some patients for years after surgery.

Identification of patients at risk of prolonged opioid use after surgery may assist in reducing the adverse outcomes associated with long-term opioid use. Pre-operative risk stratification tools may be of use in identifying surgical patients at risk of long-term opioid use. Validated tools are widely used to identify patients at high risk of opioid misuse in the chronic pain setting, but currently there is no optimal method to predict patients at risk of chronic opioid use after surgery.

Existing studies have found that a wide range of patient characteristics and psychiatric comorbidities are associated with long-term opioid use in a post-surgical setting.

There are 5 primary study procedures in the investigators research project:

  1. Enrolment in the study: Subjects will be recruited and enrolled at the pre-operative admission clinic and day surgery unit at St Vincent's Private Hospital, Sydney. This study aims to enrol 1000 patients.
  2. Informed consent: Patients who meet inclusion criteria, and agree to enrol in the study will be asked to read and sign an informed consent document.
  3. Initial questionnaire: Trained nursing staff will administer an initial questionnaire to all patients participating in the study. This questionnaire will gather data regarding potential predictors of delayed opiate cessation including age, sex, operation type, pre-operative opioid use, depression traits, anxiety traits, addictive traits, perceived susceptibility to addiction, average hours of sleep per night, history of chronic pain, and perceived general health.
  4. Follow-up questionnaire: At approximately 90 days post-surgery, a follow-up questionnaire will be administered to all enrolled subjects via phone call or email. This questionnaire will determine current pain scores and details regarding current pain medication usage.
  5. Statistical analysis: Once data collection is complete, identifying details will be removed, and data will be entered into a password-protected electronic database. The investigators will analyse data from all patients and determine the prevalence of delayed opioid cessation, and which questionnaire items independently predict delayed opioid cessation.

The investigators primary study objective is to determine the prevalence of prolonged post-surgical opioid use, defined by our study as patients taking opioids >90 days post-surgery. The investigators secondary objective is to identify patient-related factors that are independently associated with prolonged post-surgical opioid use. These factors may be used to develop a pre-operative screening tool for patients undergoing surgery, in order to assign a level of risk for chronic post-surgical opioid use.

Tipo de estudio

De observación

Inscripción (Actual)

1013

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

    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • St Vincent's Private Hospital, Sydney

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Pre-Admission Clinic, St Vincent's Private Hospital (pre-operative assessment unit) Day Surgery Unit, St Vincent's Private Hospital

Descripción

Inclusion Criteria:

  • Age ≥18 years
  • Able to give written informed consent
  • Willing to participate and comply with the study
  • Scheduled to undergo surgery at St Vincent's Private Hospital, and attending the pre-admission clinic or day surgery unit

Exclusion Criteria:

  • Opioid tolerant patients (patients who are chronically receiving opioid analgesics on a daily basis)
  • Scheduled to undergo surgery relating to malignancy
  • Surgical procedures completed under local anaesthetic
  • Minimally invasive procedures including gastroscopy, colonoscopy, bronchoscopy, cardioversion or transoesophageal echo
  • Patients who were unable to complete study questionnaires due to psychological illness, medical condition or significant language barrier were excluded from the study.

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Patients scheduled to undergo surgery
Patients scheduled to undergo surgery at St Vincent's Private Hospital Sydney
Exposure of interest: continued use of opioid analgesics >90 days post-surgery

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Continued opioid use
Periodo de tiempo: 90 days post-surgery
Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. All subjects will be contacted by investigators at 90 days post-surgery. At this point, they will be asked questions regarding their current analgesic use. This will enable us to calculate the prevalence of continued opioid use at ≥90 days post-surgery. Data collection will be complete by June 2016.
90 days post-surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain scores (score/10)
Periodo de tiempo: 90 days post-surgery
Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. All subjects will be contacted by investigators at 90 days post-surgery. At this point, they will be asked questions regarding their current pain scores out of 10. Data collection will be complete by June 2016.
90 days post-surgery
Presence of pre-operative potential predictors of delayed opioid cessation
Periodo de tiempo: 90 days post-surgery

Subjects will be recruited to the study from October 2015 to March 2016, prior to their elective surgical procedure. Subjects will complete a single questionnaire prior to surgery which will collect data including their age, sex, operation type, pre-operative opioid use, depression traits, anxiety traits, addictive traits, perceived susceptibility to addiction, average hours of sleep per night, history of chronic pain, and perceived general health.

The investigators will compare subjects with and without delayed opioid cessation to see which questionnaire items were able to independently predict continued opioid use >90 days post-surgery. Data collection will be complete by June 2016.

90 days post-surgery

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Jennifer A Stevens, MBChB, St Vincent's Hospital, Sydney

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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

1 de octubre de 2015

Finalización primaria (Actual)

1 de octubre de 2016

Finalización del estudio (Actual)

1 de octubre de 2016

Fechas de registro del estudio

Enviado por primera vez

5 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

7 de octubre de 2015

Publicado por primera vez (Estimar)

8 de octubre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de mayo de 2017

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

9 de mayo de 2017

Última verificación

1 de mayo de 2017

Más información

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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