General information
  • Disease category Lung Cancer , Surgery (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel
    (BASEC)
  • Contact Didier Lardinois didier.lardinois@usb.ch (BASEC)
  • Data Source(s) BASEC: Import from 16.04.2025 ICTRP: N/A
  • Last update 16.04.2025 09:55
HumRes66752 | SNCTP000006367 | BASEC2025-D0025

Comparison of postoperative pain with thin or thick drainage tubes after lung lobe or lung segment removal

  • Disease category Lung Cancer , Surgery (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel
    (BASEC)
  • Contact Didier Lardinois didier.lardinois@usb.ch (BASEC)
  • Data Source(s) BASEC: Import from 16.04.2025 ICTRP: N/A
  • Last update 16.04.2025 09:55

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)

Criteria for participation in trial
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)

not available

Sponsor

University Hospital Basel

(BASEC)

Contact

Contact Person Switzerland

Didier Lardinois

+41 (0)61 328 77 99

didier.lardinois@usb.ch

University 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