Assessing the Efficacy of Intravenous Acetaminophen Versus the Oral Formulation for Perioperative Pain Treatment
To compare oral (PO) to intravenous (IV) acetaminophen with postoperative pain scores, and consumptions of opiates, among orthopedic surgery patients undergoing total knee replacement with spinal anesthesia.
Our hypothesis is that IV acetaminophen patients will have improved analgesia, less opioid consumption, a lower percentage of patients rescuing, or a longer time to first rescue with IV acetaminophen. The investigators will compare the efficacies of oral and intravenous acetaminophen for postoperative pain control, and utilization of opiates as rescue agents.
Visão geral do estudo
Status
Condições
Descrição detalhada
Intravenous acetaminophen has rapid onset and potent analgesic properties. Recent studies have shown several advantages of using intravenous acetaminophen perioperatively. However, due to its relatively high cost and limited clinical data concerning its efficacy compared with other agents, physicians are hesitant to use intravenous acetaminophen in the perioperative period.
174 adult patients from the orthopedic surgeons undergoing total knee replacement with spinal anesthesia will be enrolled. The study will be double blind, randomized; placebo controlled comparing oral and IV acetaminophen to each other and a control (placebo). At the time patients arrive in the post-anesthesia care unit (PACU), Group 1 will receive IV 1 gram acetaminophen, and PO placebo; Group 2 will receive PO 1 gram acetaminophen and IV placebo; Group 3 will receive IV placebo and PO placebo.
The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale 1-10 every 15 minutes. Secondary outcomes include time to rescue analgesia (measured in minutes), time to PACU discharge (measured in minutes), and the total amount of hydromorphone (PO or IV) consumed within 6 hours postoperatively for adequate analgesia (total measured in milligrams) will be collected.
The difference in pain scores will be assessed by a chi-square test. A multivariable regression model will be performed with the clinical and statistically significant variables to remove confounding.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients undergoing total knee replacement
- Successful spinal placement
- ≥18 years old
Exclusion Criteria:
- Failed spinal anesthesia
- Chronic opiate users
- Liver disease patients
- Allergy/hypersensitivity to acetaminophen
- Patients with baseline dementia
- Patients weighing less than 50kg, history of alcohol dependence, renal impairment, opiate allergy, and pregnancy.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain scores assessed and recorded by using the numeric rating scale
Prazo: Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.
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The primary outcome that will be assessed is pain scores, which will be recorded by using the numeric rating scale, from 1-10, every 15 minutes.
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Participants will be followed for the duration of their inpatient hosptial stay, an expected average of one week.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time to rescue analgesia
Prazo: Participants will be followed for the duration of their hospital stay, an expected average of one week
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The amount of time after the surgery is completed until a patient receives rescue analgesia will be measured in minutes.
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Participants will be followed for the duration of their hospital stay, an expected average of one week
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Time to post-anesthesia care unit (PACU) discharge
Prazo: Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.
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The time from arrive in the PACU to discharge will be measured in minutes.
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Participants will be followed for the duration of their PACU stay, an expected average of 5 hours.
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Opioid Use
Prazo: Participants will be followed for six hours postoperatively.
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The investigators will collect total amount of oral and/ or intravenous hydromorphone that is consumed by for adequate analgesia.
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Participants will be followed for six hours postoperatively.
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Postoperative nausea and vomiting
Prazo: Participants will be followed for six hours postoperatively.
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The investigators will collect information on postoperative nausea and vomiting.
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Participants will be followed for six hours postoperatively.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jingping Wang, MD, Ph.D., Massachusetts General Hospital
Publicações e links úteis
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 (Estimado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2014P001139
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