Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Relieving Postoperative Pain After Thoracoscopic Surgery
The Efficacy and Safety of Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone in Patients Undergoing Video-assisted Thoracoscopic: a Multi-center Randomized Controlled Trial.
Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process. If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge. Acute pain after VATS is mainly caused by the release of inflammatory mediators after soft tissue injury at the surgical site, which activates peripheral pain receptors and leads to abnormal action potentials transmitted along A δ and C fibers. Inflammatory mediators released from the soft tissues around incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after laparoscopic surgery but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. To improve the efficiency of local incision infiltration in postoperative analgesia, at least two issues need to be addressed: prolonging the duration of analgesia and reducing inflammation of nerve surrounding tissues.
Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore whether preemptive incisional infiltration with ropivacaine plus triamcinolone is superior to ropivacaine alone in relieving postoperative pain for adults undergoing VATS. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fang Luo
- Número de teléfono: +86 13611326978
- Correo electrónico: 13611326978@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100070
- Reclutamiento
- Beijing Tiantan Hospital
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Contacto:
- Fang Luo
- Número de teléfono: +86 13611326978
- Correo electrónico: 13611326978@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients scheduled for elective thoracoscopic wedge resection, segmentectomy, and lobectomy under general anesthesia;
- Ages 18 to 64 years old
- American Society of Anesthesiologists (ASA) physical status of I-III
- Patients must be able to understand nature and potential personal consequences of the clinical trial and cooperation with follow-up investigations
- signing of the informed consent form.
Exclusion Criteria:
- History of allergies to experimental drugs such as opioids or steroids;
- Alcohol abuse; Long term use of opioid drugs (exceeding 2 weeks or 3 days per week for more than 1 month); Suspected use of sedatives and analgesics; Use analgesic drugs within 24 hours before surgery; Patients undergoing steroid therapy;
- Serious neurological disorders, severe liver and kidney dysfunction, heart failure, etc;
- Unable to use pain assessment scale;
- Pregnant or lactating patients.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Pre-incisional infiltration with 0.5%ropivacaine and triamcinolone 80mg
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Before the surgery, according to the surgeon's incision marking, the patients accept 2ml of triamcinolone (80mg) plus 15ml of 1% ropivacaine diluted with 0.9% saline to a total volume of 30ml infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).
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Comparador activo: Pre-incisional infiltration with 0.5% ropivacaine alone
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Before the surgery, according to the surgeon's incision marking, the patients accept 30ml of 0.5% ropivacaine infiltrates the incision layer by layer (1ml subcutaneous infiltration at each location, 2ml full layer infiltration, total 3ml).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Periodo de tiempo: The postoperative period 48 hours
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The postoperative period 48 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Escala de Calificación Numérica en reposo (NRSr) a 1 semana, 1 mes y 3 meses postoperatoriamente
Periodo de tiempo: Día 7 postoperatorio, mes 1 y mes 3.
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La Escala de Calificación Numérica (NRS) designa 0 como ausencia de dolor y 10 como el dolor más intenso; las puntuaciones de 1-3 indican dolor leve, 4-6 denotan dolor moderado y 7-10 significan dolor intenso.
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Día 7 postoperatorio, mes 1 y mes 3.
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Adverse events
Periodo de tiempo: Within 72 hours postoperatively
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Including local anesthetic poisoning, local hematoma, nausea and vomiting, itching, hypotension, arrhythmia, delirium, etc; Abnormal values in clinical laboratory tests, such as elevated blood glucose levels.
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Within 72 hours postoperatively
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Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
Periodo de tiempo: Data will be collected at 4、12、24、36 and 72 hours postoperatively
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The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain, scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
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Data will be collected at 4、12、24、36 and 72 hours postoperatively
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Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
Periodo de tiempo: Time Frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively
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scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain
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Time Frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively
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Patient Satisfaction Scale(PSS)
Periodo de tiempo: Postoperative hours 4、12、24 and 48 hours
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Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied".
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Postoperative hours 4、12、24 and 48 hours
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Postoperative nausea and vomiting (PONV)
Periodo de tiempo: Postoperatively within 48 hours.
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The PONV score is expressed on a scale of 0-3: 0 indicates no nausea, 1 indicates mild nausea that does not require treatment, 2 indicates nausea that requires treatment, and 3 indicates vomiting.
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Postoperatively within 48 hours.
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wound healing score at 72 h, 1 and 3 months postoperatively and patient and observer scar assessment scale (POSAS) at 72 h, 1 and 3 months.
Periodo de tiempo: Postoperative 72 hours、1 and 3 months.
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The wound healing score includes three aspects: skin healing, incision infection, and hair growth.The total score is obtained by adding up the three scores: excellent wound healing: 3; good wound: 4-5; poor wound healing: greater than or equal to 6 points. POSAS: the observer scores the scar based on the distribution of vessels, color, scar thickness, surface roughness, area, and softness around the incision, with each score ranging from 1 to 10. One indicates that the scar features are close to normal skin, and the higher the score, the more severe the scar (OSAS score); the patient evaluates the scar based on whether there is pain or itching, color, softness, thickness, and self perception. Each score range is also 1-10, with 1 indicating no difference from normal skin and a higher score indicating more severe scars. The higher the score between the two, the more severe the scar. |
Postoperative 72 hours、1 and 3 months.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY2025-338-02-4
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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