Status:
RECRUITING
16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Pneumothorax
Pleural Effusion
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The aim of the study is to evaluate postoperative pain in patients receiving a small-bore (16F) chest drain compared to those receiving the standard large-bore (24F) chest drain after minimally invasi...
Detailed Description
Lung cancer remains the leading cause of cancer-related death worldwide, and surgical resection remains the treatment of choice for patients with resectable non-small cell lung cancer (NSCLC), particu...
Eligibility Criteria
Inclusion
- Informed Consent signed by the patient (all sex and gender)
- Patients' age from ≥ 18 to ≤ 80 at time of study inclusion
- American Society of Anaesthesiologists (ASA) physical status classification I to III
- Patients with resectable non-small cell lung cancer (NSCLC) deemed operable by minimally invasive surgical technique (UICC Stages 0-II according to Tumor Nodes Metastasis (TNM) Classification 8th edition and selected patients with UICC Stage IIIA) or pulmonary metastasis or pulmonary lesion resected by lobectomy and/or segmentectomy
- Minimally invasive anatomical lung resections under general anaesthesia: lobectomy, lobectomy with wedge resection, lobectomy combined with segmentectomy, segmentectomy with wedge resection, bilobectomy
Exclusion
- Previous thoracic surgery on the same side within 6 months
- Lung cancer complicated with pleural empyema
- Patients with chronic pain who receive opiates/gabapentin/pregabalin
- Patients who consume opiates/benzodiazepines
- Congestive heart failure NYHA Class III or IV
- Liver cirrhosis Child-Pugh Class B and C
- Renal insufficiency requiring dialysis and/or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2
- Patients with coagulopathy or bleeding disorders: von Willebrand disease, Hemophilia; Thrombocytopenia (\<50 G/l), requiring platelet transfusion
- Patients with neuralgia
- Chest pain (site of surgery) without taking painkillers, measured by VAS while coughing \> 10 mm
- Rib fractures (in the last 3 months) on the side of surgical procedure
- Open anatomical lung resection, including pneumonectomy
- Insertion of 2 or more chest tubes
- Need for patient controlled intravenous anaesthesia or patient controlled epidural anaesthesia
- Patients intubated/sedated (not suitable due to difficulties to fill out the pain survey)
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2027
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06958848
Start Date
May 1 2025
End Date
August 30 2027
Last Update
December 15 2025
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031