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The Study of Perioperative Intravenous Infusion of Lidocaine on Postoperative Analgesia in Patients Undergoing Single-port Thoracoscopic

The purpose of this study is to evaluate the effect of intravenous lidocaine infusion on pain and opioid dosage in patients undergoing single-port thoracoscopic surgery,and to evaluate the effects of perioperative catecholamine levels, extubation time, incidence of nausea and vomiting, patient satisfaction and hospital stay.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

The World Congress on Pain identified pain as the "fifth leading indicator of human life" after breathing, pulse, body temperature and blood pressure. Postoperative pain is an acute nociceptive pain caused by surgical trauma and is a complex stress response in the body, especially in 72 hours after surgery. Pain after thoracic surgery is a more severe type of surgery in various types of surgery.

Acute pain at the early stage of operation is not only an external signal of body injury, but also an independent factor inducing stress response and systemic inflammatory response syndrome (SIRS). Pain stimulus can also cause excessive release of catecholamine, damage of vascular endothelial cells and neutrophil aggregation, which can induce cytokine "waterfall" secretion. Stress, pain and inflammation induce and interact with each other, which seriously affects the early recovery of patients after operation. Timely and effective post-operative analgesia can not only alleviate patients'pain, but also avoid a series of stress reactions. It provides favorable conditions for the stability of patients' physiological function and recovery of their body after operation.

Although multimodal analgesia has largely replaced monotherapy with opioids, they are still the most commonly used drugs for postoperative pain. Lidocaine is an amide local anesthetic which when used intravenously demonstrates significant analgesic, anti-hyperalgesic and anti-inflammatory properties .

Intravenous infusion of lidocaine has a good effect on fibromyalgia, chronic neuropathic pain, opioid tolerance and other chronic pain, and can reduce postoperative acute pain. In the 1960s, Barlett et al. first published a study on the use of lidocaine intravenous infusion for postoperative analgesia.Since then, more and more researchers have begun to explore the use of lidocaine in the treatment of postoperative acute pain.In 2007, Kaba et al. selected patients who underwent colectomy as an experimental subject, and intravenously injected lidocaine during the perioperative period. The results showed that the pain of the experimental group was effectively relieved and the use of opioids was reduced. In 2008, Lauwick et al. used laparoscopic cholecystectomy as the experimental subject. The results showed that the dose of opioid analgesia in the lidocaine group was significantly lower than that in the control group, and the postoperative pain was effectively improved. In 2009, Yardeni et al. selected patients undergoing total hysterectomy as experimental subjects and intravenously injected lidocaine during the perioperative period. The results confirmed that the hemodynamics of the experimental group was more stable, the average dosage of anesthetics was reduced, and the pain was significantly improved.However, to date, there is no strong evidence for the effect of perioperative intravenous infusion of lidocaine in single-port thoracoscopic surgery, so we designed this study.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

80

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jin Ma
  • Número de teléfono: 86+18867539602
  • Correo electrónico: 1241370980@qq.com

Ubicaciones de estudio

    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310009
        • Reclutamiento
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients undergoing single-port thoracoscopic with a left double lumen bronchial catheter
  • Age ≧ 18 years old, ≦70 years old
  • Temperature, white blood cells, and hemoglobin were normal before surgery
  • Patient informed consent

Exclusion Criteria:

  • Patients with a history of surgery within six months
  • Patients with dysfunction of heart, liver, kidney, lung, pancreas or other important organs
  • American Society of Anesthesiologists (ASA) physical Status classes ≧ Ⅲ
  • Allergic to lidocaine
  • Bradycardia (heart rate < 60 beats/min) or atrioventricular block
  • Mental disorder
  • Patients requiring a right double lumen bronchial catheter

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Lidocaine group
First group (lidocaine group) will include those who receive a intraoperative lidocaine infusion.Induction bolus dose of 1.5 mg/kg body weight ( 30 minutes before incision)followed by a continous lidocaine infusion of 2mg/kg/h,until 1 hours after skin closure.
regimen of lidocaine administration of 1.5 mg/kg, IV bolus, followed by continuous infusion at 2 mg/kg/h
Comparador de placebos: Saline group
The second group(saline group) will include those who receive a intraoperative placebo.The same dosage of saline was given according to the same method of administration in the lidocaine group.
IV bolus of saline, followed by continuous infusion of saline

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative pain score
Periodo de tiempo: Immediately postoperation
Using Visual Analogue Scales
Immediately postoperation
Postoperative pain score
Periodo de tiempo: 1 hour postoperation
Using Visual Analogue Scales
1 hour postoperation
Postoperative pain score
Periodo de tiempo: 4 hours postoperation
Using Visual Analogue Scales
4 hours postoperation
Postoperative pain score
Periodo de tiempo: 8 hours postoperation
Using Visual Analogue Scales
8 hours postoperation
Postoperative pain score
Periodo de tiempo: 24 hours postoperation
Using Visual Analogue Scales
24 hours postoperation
Postoperative pain score
Periodo de tiempo: 48 hours postoperation
Using Visual Analogue Scales
48 hours postoperation

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Opioid requirement
Periodo de tiempo: Immediately postoperation
The dosage of opioids was recorded
Immediately postoperation
Opioid requirement
Periodo de tiempo: 1 hour postoperation
The dosage of opioids was recorded
1 hour postoperation
Opioid requirement
Periodo de tiempo: 4 hours postoperation
The dosage of opioids was recorded
4 hours postoperation
Opioid requirement
Periodo de tiempo: 8 hours postoperation
The dosage of opioids was recorded
8 hours postoperation
Opioid requirement
Periodo de tiempo: 24 hours postoperation
The dosage of opioids was recorded
24 hours postoperation
Opioid requirement
Periodo de tiempo: 48 hours postoperation
The dosage of opioids was recorded
48 hours postoperation
Pressing times of PCIA postoperation
Periodo de tiempo: 48 hours postoperation
The pressing times of PCIA within 48 hours postoperation was recorded
48 hours postoperation
Occurrence of nausea and/or vomiting
Periodo de tiempo: 48 hours postoperation
The occurrence of nausea and vomiting within 48 hours postoperation was recorded
48 hours postoperation
Blood level of adrenaline
Periodo de tiempo: before induction
Perioperative blood level of adrenaline was recorded
before induction
Blood level of adrenaline
Periodo de tiempo: after incision
Perioperative blood level of adrenaline was recorded
after incision
Blood level of adrenaline
Periodo de tiempo: immediately after extubation
Perioperative blood level of adrenaline was recorded
immediately after extubation
Blood level of norepinephrine
Periodo de tiempo: before induction
Perioperative blood level of norepinephrine was recorded
before induction
Blood level of norepinephrine
Periodo de tiempo: after incision
Perioperative blood level of norepinephrine was recorded
after incision
Blood level of norepinephrine
Periodo de tiempo: immediately after extubation
Perioperative blood level of norepinephrine was recorded
immediately after extubation
Blood level of adrenocortical
Periodo de tiempo: before induction
Perioperative blood level of adrenocortical was recorded
before induction
Blood level of adrenocortical
Periodo de tiempo: after incision
Perioperative blood level of adrenocortical was recorded
after incision
Blood level of adrenocortical
Periodo de tiempo: immediately after extubation
Perioperative blood level of adrenocortical was recorded
immediately after extubation
Blood level of TNF-alpha
Periodo de tiempo: before induction
Perioperative blood level of TNF-alpha was recorded
before induction
Blood level of TNF-alpha
Periodo de tiempo: after incision
Perioperative blood level of TNF-alpha was recorded
after incision
Blood level of TNF-alpha
Periodo de tiempo: immediately after extubation
Perioperative blood level of TNF-alpha was recorded
immediately after extubation
Blood level of IL-6
Periodo de tiempo: before induction
Perioperative blood level of IL-6 was recorded
before induction
Blood level of IL-6
Periodo de tiempo: after incision
Perioperative blood level of IL-6 was recorded
after incision
Blood level of IL-6
Periodo de tiempo: immediately after extubation
Perioperative blood level of IL-6 was recorded
immediately after extubation
Blood level of IL-10
Periodo de tiempo: before induction
Perioperative blood level of IL-10 was recorded
before induction
Blood level of IL-10
Periodo de tiempo: after incision
Perioperative blood level of IL-10 was recorded
after incision
Blood level of IL-10
Periodo de tiempo: immediately after extubation
Perioperative blood level of IL-10 was recorded
immediately after extubation
Duration of hospital stay
Periodo de tiempo: from day of surgery until day of discharge from hospital
length of hospital stay (in days)
from day of surgery until day of discharge from hospital

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Congcong Chen, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Anticipado)

1 de agosto de 2019

Finalización primaria (Anticipado)

31 de diciembre de 2019

Finalización del estudio (Anticipado)

31 de diciembre de 2020

Fechas de registro del estudio

Enviado por primera vez

19 de julio de 2019

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2019

Publicado por primera vez (Actual)

2 de agosto de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

31 de julio de 2019

Última verificación

1 de julio de 2019

Más información

Términos relacionados con este estudio

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Lidocaine

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