- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07853456
Persistent Pain and Its Impact on Daily Life After Lung Surgery
Pain Trajectories and Pain-Related Functional Interference After Lung Resection: A Prospective Longitudinal Cohort Study
This study will examine how pain changes over the first six months after lung surgery and how it affects daily life. It will include adults scheduled for surgery to remove part or all of a lung.
The main questions are:
- How does pain change from the early days after surgery to three and six months afterward?
- Which factors before surgery and during early recovery are associated with persistent pain?
- How does pain affect walking, coughing, sleep, mood, and everyday activities?
Participants will complete questionnaires before surgery, during their hospital stay, at discharge, and at three and six months after surgery. These questionnaires will assess pain, its effects on daily life, sleep, and emotional well-being. Follow-up after discharge will be conducted by telephone or electronic questionnaires.
Researchers will also collect information from medical records about the type of surgery, surgical incisions, anesthesia, pain relief treatments, and chest drains.
This is an observational study. The research team will not assign pain treatments or change usual care. The findings may help identify patients who need additional pain assessment and support during recovery.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adults aged 18 years or older scheduled for elective lung resection at Aerospace Center Hospital, Beijing, China, will be consecutively recruited during preoperative assessment. Patients undergoing surgery for benign or malignant lung conditions through video-assisted, robot-assisted, or open approaches will be eligible. Patients with pre-existing chronic pain and those who have received neoadjuvant treatment may participate. Baseline pain and treatment history will be recorded. Participants will be followed through 6 months after surgery to assess pain persistence and pain-related interference with daily life.
Descripción
Inclusion Criteria:
- Age 18 years or older.
Scheduled for elective lung resection, including wedge resection, segmentectomy, lobectomy, bilobectomy, or pneumonectomy, through a video-assisted, robot-assisted, or open surgical approach.
Able to understand and answer the study questionnaires in Chinese, independently or with standardized assistance from research staff.
Willing to complete assessments before surgery, during hospitalization, at discharge, and at 3 and 6 months after surgery.
Provides written informed consent.
Exclusion Criteria:
- Emergency surgery.
Planned concomitant major surgery involving another organ, such as esophagectomy or cardiac surgery.
Cognitive impairment or another condition that prevents informed consent or reliable self-reported questionnaire responses despite assistance.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Incidence of Chronic Postsurgical Pain at 3 Months After Lung Resection
Periodo de tiempo: 3 months after surgery
|
3 months after surgery
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- THOR-PAIN-2026-002
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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