Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries
Optimizing the Paracetamol Dose for Prevention of Post-Spinal Shivering in Lower Limb Orthopedic Surgeries: A Randomized Controlled Trial
Shivering is a common and distressing complication following spinal anesthesia, affecting up to 70% of patients. It significantly increases oxygen consumption, places stress on the cardiovascular system, and interferes with postoperative monitoring. While intravenous paracetamol has been shown to reduce post-spinal shivering without the sedation or respiratory side effects associated with other medications, existing trials have only investigated a standard 1-gram dose. This study aims to evaluate whether a higher dose of intravenous paracetamol (2 grams) provides superior prevention of post-spinal shivering compared to the standard 1-gram dose and an inactive placebo.
Adult patients scheduled for elective lower-limb orthopedic surgery under spinal anesthesia will be randomly allocated to one of three study groups:
- High-dose group: intravenous paracetamol 2 g
- Standard-dose group: intravenous paracetamol 1 g
- Control group: intravenous normal saline placebo
Each infusion will be administered over 15 minutes immediately prior to spinal anesthesia. Participants will be observed intraoperatively and for at least 60 minutes in the post-anesthesia care unit (PACU) to measure the incidence and severity of shivering, core body temperature changes, the need for rescue medication, and any adverse events.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 18 to 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective lower-limb orthopedic surgery under spinal anesthesia
- Expected surgical duration between 1 and 3 hours
- Willingness to provide written informed consent
Exclusion Criteria:
- Patient refusal or inability to provide informed consent
- ASA physical status >= III
- Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at injection site, severe spinal deformity)
- Known allergy or hypersensitivity to paracetamol or the local anesthetic used
- Baseline (preoperative) core/tympanic temperature < 36.5°C or > 37.5°C
- Pre-existing hepatic, renal, or thyroid disorders
- History of seizure disorder
- Chronic alcohol use, malnutrition, or any condition predisposing to hepatotoxicity
- Body mass index (BMI) > 35 kg/m²
- Pregnancy or lactation
- Chronic use of antipyretic or anti-inflammatory medication within 24 hours of surgery
- Cardiac arrhythmia or hemodynamic instability
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group H: High-Dose Paracetamol (2 g)
Patients receive intravenous paracetamol 2 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous paracetamol 2 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection. |
|
Comparador Ativo: Group S: Standard-Dose Paracetamol (1 g)
Patients receive intravenous paracetamol 1 g diluted in 500 mL volume, infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous paracetamol 1 g in 500 mL volume, administered as an intravenous infusion over 15 minutes immediately prior to intrathecal injection. |
|
Comparador de Placebo: Group C: Placebo Control
Patients receive 500 mL of intravenous normal saline (0.9% sodium chloride), infused over 15 minutes, commencing immediately prior to intrathecal injection. |
Intravenous 0.9% normal saline 500 mL, infused over 15 minutes immediately prior to intrathecal injection, matched in volume and appearance to preserve blinding. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants With Clinically Significant Post-Spinal Shivering
Prazo: Up to 4 hours post-spinal injection
|
Clinically significant shivering is defined as a shivering score >= 3 on the Crossley and Mahajan Shivering Grading Scale. The scale ranges from Grade 0 to Grade 4: Grade 0 = No shivering; Grade 1 = Piloerection or peripheral vasoconstriction without visible muscular activity; Grade 2 = Muscular activity confined to one muscle group; Grade 3 = Muscular activity involving more than one muscle group, but not generalized; Grade 4 = Gross muscular activity involving the whole body. Higher grades indicate greater shivering severity. |
Up to 4 hours post-spinal injection
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
- Paracetamol Dose for Shivering
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