Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery
1 de enero de 2020 actualizado 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.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
124
Fase
- No aplica
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.
Ubicaciones de estudio
-
-
Jiangsu
-
Xuzhou, Jiangsu, Porcelana, 225000
- Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
-
-
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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: ropivacaine combined with mecobalamine
Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
|
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.
|
|
Comparador activo: ropivacaine
Intercostal nerve block with 0.5% ropivacaine alone.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of chronic pain after chest surgery
Periodo de tiempo: At the 3rd month after surgery
|
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".
|
At the 3rd month after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The incidence of acute pain after chest surgery
Periodo de tiempo: 24 to 72 hours after surgery
|
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".
|
24 to 72 hours after surgery
|
|
Incidence of postoperative neuropathic pain
Periodo de tiempo: At the 3rd month after surgery
|
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".
|
At the 3rd month after surgery
|
|
Incidence of other postoperative complications
Periodo de tiempo: At the 3rd month after surgery
|
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.
|
At the 3rd month after surgery
|
|
Incidence of readmission within 30 days after surgery
Periodo de tiempo: At the 30 days after surgery
|
The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
|
At the 30 days after surgery
|
|
Incidence of death within 30 days after surgery
Periodo de tiempo: At the 30 days after surgery
|
The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
|
At the 30 days after surgery
|
|
Length of stay
Periodo de tiempo: At the 3rd month after surgery
|
The total length of hospital stay.
|
At the 3rd month after surgery
|
|
Cost of stay
Periodo de tiempo: At the 3rd month after surgery
|
The total cost of hospital stay.
|
At the 3rd month after surgery
|
|
icu length of stay
Periodo de tiempo: At the 3rd month after surgery
|
The number of hours of postoperative stay in ICU.
|
At the 3rd month after surgery
|
|
Incidence of secondary operation
Periodo de tiempo: At the 3rd month after surgery
|
Whether the patient has a second operation and the reason and the incidence of this operation.
|
At the 3rd month after surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 enero de 2020
Finalización primaria (Anticipado)
30 de junio de 2020
Finalización del estudio (Anticipado)
30 de noviembre de 2020
Fechas de registro del estudio
Enviado por primera vez
30 de noviembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
1 de enero de 2020
Publicado por primera vez (Actual)
3 de enero de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de enero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
1 de enero de 2020
Última verificación
1 de enero de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- XYFY2019-KL169-01
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 Intercostal nerve block
-
FluidAI MedicalReclutamientoFuga anastomóticaEstados Unidos, Canadá, Arabia Saudita
-
NERv Technology IncUnity Health TorontoTerminadoFuga anastomóticaEgipto
-
Damascus UniversityTerminadoComplicación del aparato de ortodoncia | Maloclusión, Clase II de Angle, División 1República Árabe Siria
-
Guy's and St Thomas' NHS Foundation TrustDesconocidoMaloclusión, clase de ángulo II
-
University of BirminghamDesconocidoMaloclusión, clase de ángulo IIReino Unido
-
AtriCure, Inc.Inscripción por invitaciónDolor postoperatorioEstados Unidos
-
Assiut UniversityAún no reclutando
-
Assiut UniversityDesconocido
-
FluidAI MedicalHamilton Health Sciences Corporation; Ontario Bioscience Innovation OrganizationReclutamiento
-
Cairo UniversityDesconocidoHipoplasia mandibular | Retrognatismo mandibularEgipto