Um estudo de injeção de lipossoma de bupivacaína na analgesia local de pacientes pediátricos
Um estudo do mundo real sobre infiltração local de injeção de lipossoma de bupivacaína para dor aguda pós-operatória após cirurgia ortopédica pediátrica
The study is being conducted to evaluate the safety and efficacy of bupivacaine liposome injection for local infiltration analgesia in pediatric orthopedic surgery in the real world.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Thea Yu
- Número de telefone: +86-0518-82342973
- E-mail: suyang.yu.sy17@hengrui.com
Locais de estudo
-
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Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recrutamento
- Guangzhou Women and Children's Medical Center
-
Contato:
- Xingrong Song
- E-mail: sxjess@126.com
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Investigador principal:
- Xingrong Song
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Subjects and guardians are willing to sign the informed consent.
- Subjects undergoing orthopedic surgery under general anesthesia with expected cumulative incision length ≥ 3cm.
- 6 years old ≤ age ≤ 17 years old, Male or female.
- ASA Physical Status Classification I-III.
Exclusion Criteria:
- Subjects received liposomal bupivacaine or bupivacaine hydrochloride within the past 30 days.
- Subjects with a history of immunodeficiency diseases (such as congenital immunodeficiency disease, AIDS or malignant tumors) or received immunosuppressants within 30 days.
- Subjects with comorbid mental diseases (such as schizophrenia, depression, etc.) or difficult to communicate.
- Subjects with a history of chronic pain or visceral pain.
- Subjects with abnormal liver and kidney function.
- Subjects with clinically significant abnormal heart rate or rhythm.
- Subjects who are participating or planning to participate in any interventional clinical trial.
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Injeção de lipossoma de bupivacaína
|
Bupivacaine Liposome Injection 4 mg/kg (up to a maximum of 266 mg) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The incidence of Treatment Emergent Adverse events (TEAE) in the cardiac and nervous system
Prazo: 0 minute to 14 days after administration
|
Proportion of patients with any TEAE of cardiac or nervous system in MedDRA (Medical Dictionary for Regulatory Activities). |
0 minute to 14 days after administration
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The cumulative amount of opioids used in 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
Prazo: 0 minute to 72 hours after administration
|
Total consumption of opioids during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration. |
0 minute to 72 hours after administration
|
|
Time to first rescue analgesia of opioid
Prazo: 0 minute to 72 hours after administration
|
Duration from administration to first use of opioid for rescue analgesia. |
0 minute to 72 hours after administration
|
|
The proportion of patients who did not use rescue analgesia during 0-24 hours, 24-48 hours, 48-72 hours and 0-72 hours after administration
Prazo: 0 minute to 72 hours after administration
|
The proportion of patients who did not use rescue analgesia during 72 hours after administration. |
0 minute to 72 hours after administration
|
|
The proportion of patients using patient-controlled intravenous analgesia (PCIA)
Prazo: 0 minute to 72 hours after administration
|
The proportion of patients who used patient-controlled intravenous analgesia (PCIA) during 0-72 hours after administration. |
0 minute to 72 hours after administration
|
|
Pain intensity score at rest after administration for children aged 6 to 7 years
Prazo: 0 minute to 72 hours after administration
|
Wong Baker Faces Pain Scale Revision (FPS-R，0 indicates no pain and 10 indicates the most severe pain) was used for children aged 6 to 7 years at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes). |
0 minute to 72 hours after administration
|
|
Pain intensity score at rest after administration for children aged 8 years and older
Prazo: 0 minute to 72 hours after administration
|
Numerical Rating Scale (0 indicates no pain and 10 indicates the most severe pain) was used for children aged 8 years and older to assess the intensity of pain at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes). |
0 minute to 72 hours after administration
|
|
Pain intensity score on movement (or cough) after administration for children aged 6 to 7 years
Prazo: 0 minute to 72 hours after administration
|
Wong Baker Faces Pain Scale Revision (FPS-R，0 indicates no pain and 10 indicates the most severe pain) was used for children aged 6 to 7 years at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes). |
0 minute to 72 hours after administration
|
|
Pain intensity score on movement (or cough) after administration for children aged 8 years and older
Prazo: 0 minute to 72 hours after administration
|
Numerical Rating Scale (0 indicates no pain and 10 indicates the most severe pain) was used for children aged 8 years and older to assess the intensity of pain at the time of 30minutes after awakening (including 30minutes), 6hours (±30minutes), 12hours (±30minutes), 18hours (±30minutes), 24hours (±30minutes), 36hours (±30minutes), 48hours (±30minutes) and 72hours (±30minutes). |
0 minute to 72 hours after administration
|
|
Length of Stay
Prazo: Up to 2 weeks
|
The score of Post-Anesthetic Discharge Scoring System Scale (PADSS) was used to determine whether the patient could be discharged. |
Up to 2 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Outros números de identificação do estudo
- ZYWB-ZM-AHP-A-003
Plano para dados de participantes individuais (IPD)
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