RecruitingNot ApplicableNCT06958848

16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy

Comparison of 16F Versus 24F Chest Drain After Minimally Invasive Pulmonary Lobectomy and/or Segmentectomy: a Monocentre Prospective Randomized Controlled Trial


Sponsor

University Hospital, Basel, Switzerland

Enrollment

124 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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 invasive pulmonary lobectomy and/or segmentectomy.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria15

  • 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)

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Interventions

DEVICE16 F chest tube

Insertion of 16F chest tube

DEVICE24 F chest tube

Insertion of 24F chest tube

PROCEDUREEarly removal

Removal 2-6h after end of skin closure

PROCEDUREStandard removal

Removal 1day postoperative


Locations(1)

University Hospital Basel

Basel, Switzerland

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NCT06958848


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