- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Incidence of Chronic Postsurgical Pain at 3 Months After Lung Resection
Délai: 3 months after surgery
|
3 months after surgery
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- THOR-PAIN-2026-002
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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