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- Ensaio Clínico NCT02061774
Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion
Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion After Administration of Preoperative Followed by Scheduled Intravenous Acetaminophen:
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. The advantages of intravenous acetaminophen are well known in the literature and its opioid-sparing effects have been documented in multiple surgical studies.
Multimodal regimens are now being advocated in the literature to decrease opioid use (8, 23). This is especially significant in spine surgery patients who often have chronic pain requiring long-term use of these habit-forming drugs as well as in patients who may not be able to tolerate opiods due to health status.
To our knowledge there are no studies done in the U.S. on the opioid sparing and pain reducing effects of intravenous acetaminophen on patients undergoing elective minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. Investigating intravenous acetaminophen, particularly its pain reducing and opioid sparing effects, may give surgeons another medication for use in a multimodal approach to pain.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Texas
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Lubbock, Texas, Estados Unidos, 79430
- Texas Tech University Health Science Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age > 18 years old
- Being scheduled to have elective primary minimally invasive 1 or 2 level transforaminal lumbar laminectomy interbody fusion
- ASA I, II, or III
- Informed consent form signed
Exclusion Criteria:
- Anyone weighing less than 50kg (as this would require a dosing change).
- Hypersensitivity or contraindication to intravenous acetaminophen or opioids
- Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl
- Impairment of liver function-- defined as the inability to receive intravenous acetaminophen without dose adjustment as determined by the investigator; or history of chronic liver disease defined as history of hepatitis of any kind as recorded in the patient's chart
- Mental retardation recorded as a diagnosis in the patient's chart
- History of chronic pain (defined as currently receiving treatment from a specialist for pain)
- History of pain recalcitrant to intravenous morphine
- Impaired kidney function (defined as creatinine > 1.5)
- Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: acetaminophen
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
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1 gram of intravenous Acetaminophen
Outros nomes:
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Comparador de Placebo: PlaceboComparator
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
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placebo comparator .9%
NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
VAS
Prazo: Q4 x 24 hours averaged
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The Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) will be measured at 4 hour intervals for a 24-hr period - measures of pain intensity in clinical and research settings.
0-10 Numeric pain intensity scale.
0 is no pain, 5 is moderate pain, and 10 is worst possible pain
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Q4 x 24 hours averaged
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Level of 100% Sedation
Prazo: 4-hr intervals for a 24-hr period averaged
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Sedation will be measured on a scale of 1 to 5 at 4-hour intervals as follows: 1-completely awake; 2-awake but drowsy; 3 asleep, but responds to verbal commands; 4-asleep but responds to tactile stimuli; and 5-asleep and not responding to any stimuli.
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4-hr intervals for a 24-hr period averaged
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Vital Signs
Prazo: 4-hour intervals (+/- 30 minutes) for 24-hrs averaged
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Routine postoperative vital signs will be collected at 4-hour intervals (+/- 30 minutes) postoperatively respiratory rate, oxygen saturation, mean arterial pressure, and heart rate.
Any reports of headache, dizziness, nausea, vomiting, pruritis, agitation, constipation, insomnia, bradycardia (Heart rate below 60 beats per minute), hypotension (MAP less than 30% of baseline), or urinary retention will be recorded throughout the study and will be treated appropriately as they occur, and the treatment medication will be stopped if determined to be a causative factor.
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4-hour intervals (+/- 30 minutes) for 24-hrs averaged
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Total PCA Morphine
Prazo: Duration of operation
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Amount of morphine used during surgery
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Duration of operation
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jason Felton, MD, TTUHSC department of Surgery
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
- L14-015
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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