Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery
1 de janeiro de 2020 atualizado por: Han Yuan, Xuzhou Medical University
Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients.
Related clinical characteristics of postoperative chronic pain.
The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals.
And public resources.
Visão geral do estudo
Status
Desconhecido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Antecipado)
124
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Jiangsu
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Xuzhou, Jiangsu, China, 225000
- Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Age ≥18 years old, conscious;
- ASA class Ⅰ ~ Ⅲ;
- Thoracoscopic lobectomy was proposed;
- The han nationality;
- Native speaker of Chinese;
- Agree to participate in this study and sign the informed consent.
Exclusion Criteria:
- Patients allergic to meccobalamin or ropivacaine;
- Patients with previous history of chest surgery;
- Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;
- Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;
- Diabetic patients;
- Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: ropivacaine combined with mecobalamine
Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
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In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity.
5ml was injected into each intercostal nerve block.
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Comparador Ativo: ropivacaine
Intercostal nerve block with 0.5% ropivacaine alone.
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In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity.
5ml was injected into each intercostal nerve block.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of chronic pain after chest surgery
Prazo: At the 3rd month after surgery
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The incidence of chronic pain after chest surgery was measured by NRS(numeric rating scales) at the 3rd month after surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".
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At the 3rd month after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The incidence of acute pain after chest surgery
Prazo: 24 to 72 hours after surgery
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An NRS score was performed 24 to 72 hours after surgery to determine the incidence of acute pain after thoracic surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".
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24 to 72 hours after surgery
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Incidence of postoperative neuropathic pain
Prazo: At the 3rd month after surgery
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The incidence of neuropathic pain was measured by DN4 scale at the 3rd month after surgery.Douleur Neuropathique 4 (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research,where a DN4 scores greater than or equal to 4 represented the patients had "postoperative neuropathic pain".
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At the 3rd month after surgery
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Incidence of other postoperative complications
Prazo: At the 3rd month after surgery
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Postoperative complications included that pulmonary complications, delirium, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, incision infection, cerebrovascular accident and other complications related to surgery.
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At the 3rd month after surgery
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Incidence of readmission within 30 days after surgery
Prazo: At the 30 days after surgery
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The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
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At the 30 days after surgery
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Incidence of death within 30 days after surgery
Prazo: At the 30 days after surgery
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The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
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At the 30 days after surgery
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Length of stay
Prazo: At the 3rd month after surgery
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The total length of hospital stay.
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At the 3rd month after surgery
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Cost of stay
Prazo: At the 3rd month after surgery
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The total cost of hospital stay.
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At the 3rd month after surgery
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icu length of stay
Prazo: At the 3rd month after surgery
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The number of hours of postoperative stay in ICU.
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At the 3rd month after surgery
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Incidence of secondary operation
Prazo: At the 3rd month after surgery
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Whether the patient has a second operation and the reason and the incidence of this operation.
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At the 3rd month after surgery
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Antecipado)
1 de janeiro de 2020
Conclusão Primária (Antecipado)
30 de junho de 2020
Conclusão do estudo (Antecipado)
30 de novembro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
30 de novembro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de janeiro de 2020
Primeira postagem (Real)
3 de janeiro de 2020
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de janeiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de janeiro de 2020
Última verificação
1 de janeiro de 2020
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- XYFY2019-KL169-01
Informações sobre medicamentos e dispositivos, documentos de estudo
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Não
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