Comparison of postoperative pain with thin or thick drainage tubes after lung lobe or lung segment removal
Descrizione riassuntiva dello studio
At the end of a lung surgery where a lung lobe or lung segment has been removed, a tube is inserted into the chest (also known as chest drainage). The tube drains wound fluid and air from the chest. The placement of a large-bore tube (24 F) after lung segment removal is currently considered standard procedure. The tube can cause pain and interfere with the patient's breathing exercises. Therefore, according to current understanding, the tube is removed as soon as it is no longer necessary. The tube is usually removed starting from the first postoperative day. In this study, we want to find out whether patients with a small-bore (16 F) tube in the chest experience less postoperative pain. Additionally, we want to investigate pain relief after early removal of the tube. The postoperative complications in patients with early removal of the tube from the chest will be compared with those in whom the tube was removed starting from the first day after surgery.
(BASEC)
Intervento studiato
The study intervention being investigated is the placement of a chest drain with a thin tube following lung surgery. Depending on randomization, either a small-bore (16 F) or a large-bore (24 F) tube will be inserted.
Postoperatively, the intensity of chest pain in the surgical area will be measured using the visual analog scale (VAS), which is provided to the patient on a sheet of paper. The visual analog scale is a widely recognized scale.
Chest pain intensity will be measured and documented at rest and during coughing. The patient marks their responses with a vertical line on the horizontal marking line of the sheet. The evaluation is done by measuring the distance from the starting anchor point (0) to the marking; the recorded values are documented in millimeters (0-100). Assessment will take place 2, 4, 6 hours after the end of the operation and then daily between 7–8 AM and 5–6 PM until the third day or until the tube is removed.
(BASEC)
Malattie studiate
Resectable non-small cell lung carcinoma. Lung metastases. Lung changes with suspicion of a malignant disease.
(BASEC)
Resectable non-small cell lung carcinoma. Lung metastases. Lung changes with suspicion of a malignant disease. Thoracoscopic (=keyhole surgery) anatomical lung segment removal under general anesthesia. (BASEC)
Criteri di esclusione
Previous chest surgeries on the same side within 6 months. Chronic pain. Severe heart, liver, and kidney diseases. Bleeding disorders. Nerve diseases. Chest pain (in the surgical area) when coughing of > 10 mm preoperatively. (BASEC)
Luogo dello studio
Basilea
(BASEC)
Sponsor
University Hospital Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Didier Lardinois
+41 (0)61 328 77 99
didier.lardinois@clutterusb.chUniversity Hospital Basel
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
16.04.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Comparison of 16F versus 24F chest drain after thoracoscopic lobectomy and/or segmentectomy: a monocentre prospective randomized controlled trial. (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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