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Standardization of Post-operative Opiate Prescriptions for Same-day Ankle and Wrist Fracture Surgeries

3 de abril de 2022 atualizado por: Zoe Rubin, The Ottawa Hospital

The purpose of this prospective cohort study is to evaluate the opiate prescribing patterns post open reduction and internal fixation (ORIF) of wrist and ankle fractures at the Ottawa Hospital.

The primary objective would be to examine the quantity and duration of opiates consumed by the study population, as well as the participant's overall satisfaction with pain control. the investigators will assess whether there is a discrepancy between the quantity of pills prescribed and what is being consumed.

With the data collected, the secondary objective would be to create a standardized pain prescription, which the investigators would implement in the second phase of this prospective study. Opiate pills consumed, pain satisfaction and left-over narcotics would again be assessed.

The overall goal of this study is to produce an appropriate standardized post-operative prescription, where the number of opiates prescribed mirrors what is being consumed. This would cut down on the quantity of left-over narcotics, helping to reduce the incidence of opiate dependency and diversion in the Ottawa community.

Visão geral do estudo

Descrição detalhada

This is a multiphase study that will begin with a retrospective review of the prescribing patterns at the Ottawa Hospital. The post-operative prescriptions of 50 wrist fracture and 50 ankle fracture patients booked for same day fracture fixation will be reviewed. The type and quantity of opiate pills prescribed, as well as the other multimodal analgesics prescribed will be collected. Phase one will provide the investigators with data regarding the recent prescribing trends at the Ottawa Hospital prior to beginning the prospective phase of the study.

Phase two and three of the study involves collecting data from two prospectively collected cohorts - the standard of care cohort (phase 2) and the standardized prescription cohort (phase 3).

In phase two, eligible wrist and ankle fracture patients booked for open reduction and internal fixation through the Walking Wounded (emergency day surgery) program will be recruited and consented via telephone prior to their surgery date. The study participants will receive a post-operative prescription at the discretion of their attending surgeon, fellow or resident, with no intervention from the researchers involved in this study. On post-operative day three and post-operative day ten, these patients will be contacted by phone by the research team and asked to respond verbally to a questionnaire that will record the following measures - quantity of opiates consumed/left-over, pain intensity, satisfaction with pain treatment and other non-opiate medications taken.

Using the data collected from phase two, a standardized pain prescription will be created. The average quantity of opiates consumed by the phase two participants will be used to guide the quantity of opiates to be prescribed on the standardized prescription. Similar to recruitment in phase two, in phase three, all eligible patients will be contacted and recruited by telephone prior to their surgery. These patients will be flagged on the day of surgery and given the standardized prescription post-operatively. They will then be asked to respond to the same questionnaires via telephone on post-op day three and post-op day ten.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Zoe Rubin, M.D.
  • Número de telefone: 5147549514
  • E-mail: zrubin@toh.ca

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Ankle and wrist fracture patients booked for ORIF (via Walking Wounded program)
  • Opioid naïve (Opiates prescribed in emergency not included)
  • Competent to give informed consent and respond to questionnaires independently
  • English or French speaking

Exclusion Criteria:

  • Admission to hospital pre- or post-operatively
  • Chronic opioid use for pain unrelated to injury
  • Chronic pain in injured extremity, unrelated to acute injury
  • Previous fracture/surgery to injured limb
  • Revision ORIF
  • Dementia or cognitive impairment

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Standard of care cohort
Eligible wrist and ankle fracture patients booked for open reduction and internal fixation through our emergency day surgery program will be recruited and consented via telephone prior to their surgery date. The study participants will receive a post-operative prescription at the discretion of their attending surgeon, fellow or resident, with no intervention from the researchers involved in this study. On post-operative day three and post-operative day ten, these patients will be contacted by phone by the research team and asked to respond verbally to a questionnaire. Measures including quantity of opiates consumed, pain intensity and satisfaction with pain treatment will be recorded.
Experimental: Standardized prescription cohort
Using the data collected from the standard of care cohort, a standardized pain prescription will be created. The average quantity of opiates consumed by the standard of care participants will be used to guide the quantity of opiates to be prescribed on the standardized prescription. In this arm, all eligible patients will be contacted and recruited by telephone prior to their surgery. These patients will be flagged on the day of surgery and given the standardized prescription post-operatively. They will then be asked to respond to the same questionnaires as the standard of care cohort via telephone on post-op day three and post-op day ten.
The standardized prescription will include a single opiate, with a fixed dose and number of tablets. It will also include non-opiate adjuncts commonly prescribed at our institution, namely acetaminophen and an anti-inflammatory medication.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Patient reported pain satisfaction
Prazo: Measures will be recorded on days 3 postoperatively
Patient reported pain satisfaction between those receiving standard of care, and those receiving the novel standardized prescription will be compared. Treatment satisfaction will be measured using the 11-point ordinal rating of pain intensity (numeric rating scale) and an 11-point ordinal rating of satisfaction with pain relief. In addition to the numerical rating scale, A verbal rating scale (VRS), will also be used to qualify pain control. The VRS consists of a list of descriptors that represent varying degrees of pain intensity. Each of these descriptors has a number associated with it (e.g., 0 = none, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = intolerable pain). Comparable to the VRS, the Likert scale will similarly be used to qualify treatment satisfaction (e.g., 0 = Very satisfied, 1 = somewhat satisfied, 2 = neither satisfied nor dissatisfied, 3 = somewhat dissatisfied, and 4 = very dissatisfied).
Measures will be recorded on days 3 postoperatively
Patient reported pain satisfaction
Prazo: Measures will be recorded on day 10 postoperatively
Patient reported pain satisfaction between those receiving standard of care, and those receiving the novel standardized prescription will be compared. Treatment satisfaction will be measured using the 11-point ordinal rating of pain intensity (numeric rating scale) and an 11-point ordinal rating of satisfaction with pain relief. In addition to the numerical rating scale, A verbal rating scale (VRS), will also be used to qualify pain control. The VRS consists of a list of descriptors that represent varying degrees of pain intensity. Each of these descriptors has a number associated with it (e.g., 0 = none, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = intolerable pain). Comparable to the VRS, the Likert scale will similarly be used to qualify treatment satisfaction (e.g., 0 = Very satisfied, 1 = somewhat satisfied, 2 = neither satisfied nor dissatisfied, 3 = somewhat dissatisfied, and 4 = very dissatisfied).
Measures will be recorded on day 10 postoperatively

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Average quantity of opioids prescribed in the standard of care cohort measured using morphine equivalents.
Prazo: Prescription information will be collected at a single point prior to post-operative day 3.
The quantity of opioids prescribed per patient will be converted to Morphine Milligram Equivalents (MME). Data on quantity and types of opiates prescribed, as well as other non-opiate adjuncts, will be collected through EPIC, our institution's electronic health records system.
Prescription information will be collected at a single point prior to post-operative day 3.
Average quantity of opioids consumed post-operatively in both cohorts
Prazo: Measures will be recorded on day 3 postoperatively
The quantity of opiates consumed per patient will be collected on post-operative day three, by asking the study participant to count the number of pills remaining in their opiate prescription bottle.
Measures will be recorded on day 3 postoperatively
Average quantity of opioids consumed post-operatively in both cohorts
Prazo: Measures will be recorded on day 10 postoperatively
The quantity of opiates consumed per patient will be collected on post-operative day ten, by asking the study participant to count the number of pills remaining in their opiate prescription bottle.
Measures will be recorded on day 10 postoperatively
Average quantity of left-over/unused opiates
Prazo: Post-operative day 10
The quantity of opiates remaining per patient will be collected on post-operative day ten, by asking the study participant to count the number of pills remaining in their opiate prescription bottle.
Post-operative day 10
Distribution of use of different opioids and non-opioid adjuncts prescribed
Prazo: Prescription information will be collected at a single point prior to post-operative day 3.
The variety of different opiate molecules and non-opiate adjuncts prescribed will be collected and the frequency that each type is being used at our institution will be analyzed.
Prescription information will be collected at a single point prior to post-operative day 3.
The difference in consumption patterns between patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic.
Prazo: Measures will be recorded on days 3 postoperatively
Average quantity of opioids consumed post-operatively will be compared between the patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic.
Measures will be recorded on days 3 postoperatively
The difference in consumption patterns between patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic.
Prazo: Measures will be recorded on day 10 postoperatively
Average quantity of opioids consumed post-operatively will be compared between the patients receiving peripheral nerve blocks versus those who haven't received a regional anesthetic.
Measures will be recorded on day 10 postoperatively

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

1 de maio de 2022

Conclusão Primária (Antecipado)

1 de dezembro de 2022

Conclusão do estudo (Antecipado)

1 de dezembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

9 de fevereiro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de abril de 2022

Primeira postagem (Real)

12 de abril de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de abril de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de abril de 2022

Última verificação

1 de abril de 2022

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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