Comparison of postoperative pain with thin or thick drainage tubes after lung lobe or lung segment removal
Summary description of the study
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)
Intervention under investigation
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)
Disease under investigation
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)
Exclusion criteria
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)
Trial sites
Basel
(BASEC)
Sponsor
University Hospital Basel
(BASEC)
Contact
Contact Person Switzerland
Didier Lardinois
+41 (0)61 328 77 99
didier.lardinois@clutterusb.chUniversity Hospital Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
16.04.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Comparison of 16F versus 24F chest drain after thoracoscopic lobectomy and/or segmentectomy: a monocentre prospective randomized controlled trial. (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available