- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05360433
Too Much of a Good Thing? Impact of Initial Prescription Size in Post-cesarean Section Pain Management
Impact of Reduced Initial Prescription Size on Opioid Consumption in Postoperative Pain Management for Scheduled Cesarean Deliveries
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
All faculty scheduled cesarean deliveries will be eligible for possible enrollment. Once patients are scheduled for delivery, their providers will grant permission for potential participation in the study. Two weeks prior to surgery, potential participants will receive a phone call to assess interest and eligibility for participation. During the phone call, investigators will explain the goals of this research project and the overall study design. If an individual expresses interest in participation during this initial phone call, investigators will administer an intake survey. The intake survey is designed to collect data on participant eligibility as well as preexisting attitudes and experiences that may influence postoperative opioid consumption.
Patients who complete the initial survey will be approached by a member of the research team on postoperative day two or three prior to discharge from the hospital. At this time, investigators will obtain informed consent and provide each participant with an enrollment packet prepared by the principal investigator. The enrollment packet will contain educational components including information about opioids with specific instructions about how to use opioids for pain management and instructions on proper disposal of unused tablets. Investigators will also include information about alternative forms of analgesia (ibuprofen and acetaminophen) with FDA approved instructions regarding their use in pain management. The study team's goal in including these educational components for each study group is to ensure that women are able to make safe and informed decisions regarding both forms of medication for optimal pain management. The enrollment packet will also include copies of all surveys the participants will be completing and a visual representation of the numerical pain scale for participants to reference.
Women in the study will be randomized to receive either 10 or 20 tablets of oxycodone 5 mg upon discharge. Randomization of prescription groups will be achieved using a computer randomized sequence assigning participants in a 1:1 ratio to either a standard discharge prescription size (20 tablets oxycodone 5mg) or a reduced initial prescription size (10 tablets oxycodone 5 mg). Participants will not be given information regarding prescription size of other participants in the study, and will therefore be blinded as to whether or not their prescription size represents the larger or smaller group.In the event that a participant should require more opioid tablets for pain medication, there will be an option to request a refill from a designated provider. Refills across both groups will be standardized to a size of 5 tablets and healthcare providers will be notified of the participant's request in order to help determine if an earlier postoperative visit is needed for evaluation.
Outcome metrics will be collected at 3 different postoperative time points. The initial "inpatient survey" will be completed in person at the time of consent on postoperative day two or three. This survey is designed to collect information about each participant's perceived pain experience during inpatient stay and capture pain rating at time of discharge. Outcome metrics at two subsequent time points (10-14 days post-op and 6 weeks post-op) will be collected using an "outpatient survey." Participants will be given the option to complete the outpatient surveys over the phone with the investigator directly inputting metrics or through an online survey directly linked to the study electronic database. Follow-up surveys will assess a number of outcome metrics related to opioid use, participant's pain experience, and participant satisfaction with pain management.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Robyn N Goodrich, BA
- Número de telefone: 434-825-7630
- E-mail: rgoodrich@vt.edu
Estude backup de contato
- Nome: Jaclyn D Nunziato, MD
- Número de telefone: 540-655-0459
- E-mail: jdnunziato@carilionclinic.org
Locais de estudo
-
-
Virginia
-
Roanoke, Virginia, Estados Unidos, 24014
- Recrutamento
- Carilion Roanoke Memorial Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Female
- Age 19-40 years old
- Pregnant
- Scheduled to undergo cesarean section at Carilion Roanoke Memorial Hospital
- opioid naïve (defined as no opioid use within 30 days of surgery
Exclusion Criteria:
- History of chronic pain
- History of opioid use disorder
- History of any known intolerance or allergies to analgesics
- Women with postoperative complications (hysterectomy during or after birth, bowel or bladder injury during birth, need for re-operation, or immediate wound complication)
- Language barrier preventing screening or consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 10 tablet prescription group
These participants receive 10 tablets of oxycodone 5 mg at discharge for postoperative pain.
|
Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.
Outros nomes:
|
|
Comparador Ativo: 20 tablet prescription group
These participants receive 20 tablets of oxycodone 5 mg at discharge for postoperative pain.
|
Reduced initial prescription of oxycodone for postoperative pain management following cesarean section.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total opioid consumption by participants post-cesarean delivery
Prazo: 2 weeks
|
Number of tablets of oxycodone consumed for postoperative pain management.
This will be measured by a pill count at the participant's 2 week post-op visit and the participant's responses to postoperative surveys at 2 weeks and 6 weeks post surgery.
|
2 weeks
|
|
Total opioid consumption by participants post-cesarean delivery
Prazo: 6 weeks
|
Number of tablets of oxycodone consumed for postoperative pain management.
This will be measured by a pill count at the participant's 2 week post-op visit and the participant's responses to postoperative surveys at 2 weeks and 6 weeks post surgery.
|
6 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participant pain rating
Prazo: 2 weeks
|
reported level pain based on Numeric Pain Rating Scale (NPRS) 0-10, with 0 being no pain and 10 being the worst pain imaginable
|
2 weeks
|
|
Participant pain rating
Prazo: 6 weeks
|
reported level pain based on Numeric Pain Rating Scale (NPRS) 0-10, with 0 being no pain and 10 being the worst pain imaginable
|
6 weeks
|
|
Participant satisfaction with pain management
Prazo: 2 weeks
|
Patient reported satisfaction with postoperative pain management on survey based on opinion of whether medications provided were strong enough and the quantity of medication provided Participants are asked "were you overall satisfied with your pain management since surgery" and answer yes or no
|
2 weeks
|
|
Participant satisfaction with pain management
Prazo: 6 weeks
|
Patient reported satisfaction with postoperative pain management on survey based on opinion of whether medications provided were strong enough and the quantity of medication provided Participants are asked "were you overall satisfied with your pain management since surgery" and answer yes or no
|
6 weeks
|
|
Requests for opioid prescription refills by participants
Prazo: 2 weeks
|
Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative
|
2 weeks
|
|
Requests for opioid prescription refills by participants
Prazo: 6 weeks
|
Number of opioid refills required by participant requesting additional medication up to 6 weeks post operative
|
6 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jaclyn D Nunziato, MD, Carilion Clinic
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 19-516
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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