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

ConditionsPneumothoraxPleural Effusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Informed Consent signed by the patient (all sex and gender)

Patients' age from ≥ 18 to no age limit at time of study inclusion

American Society of Anaesthesiologists (ASA) physical status classification I to IV

Patients with resectable non-small cell lung cancer (NSCLC) deemed operable by minimally invasive surgical technique.

Disqualifiers

Previous thoracic surgery on the same side within 3 months

Lung cancer complicated with pleural empyema

Patients with chronic pain who receive opioids/gabapentin/pregabalin

Patients who consume opiates/benzodiazepines

Trial design

Design model

Parallel

Treatments tested in this trial

  • 16 F chest tube

    Device

    Insertion of 16F chest tube

  • 24 F chest tube

    Device

    Insertion of 24F chest tube

  • Early removal

    Procedure/Surgery

    Removal 2-6h after end of skin closure

  • Standard removal

    Procedure/Surgery

    Removal 1day postoperative

Treatment groups

124 Participants
are divided into 4 treatment groups
Group A: 16F - early removalExperimental treatment 2 interventions
Group B: 16F - standard removalExperimental treatment 2 interventions
Group C: 24F - early removalExperimental treatment 2 interventions
Group D: 24F - standard removalActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Postoperative chest pain

Postoperative pain related to the placed chest drain (16F versus 24F), measured on a visual analogue scale (VAS) while coughing at different time points from skin closure until standard chest drain removal. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm). Chest pain intensity is measured and recorded at rest and while coughing. For the current pain rating, the patient must be shown their last rating for comparison. The patient marks their information with a vertical line on the horizontal score line of the sheet paper. If needed, assistance with filling out the form will be provided. The evaluation is carried out by measuring the distance from the low anchor point to the marking; the recorded values are expressed in millimetres (0-100).

Time frame
4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
2

Postoperative acute pain relief while coughing

Postoperative acute pain relief while coughing in the other 5 pairwise comparisons. Pain is measured on a visual analogue scale (VAS) while coughing. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm).

Time frame
4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.

Secondary outcomes

1

Postoperative acute pain relief at rest

Postoperative acute pain relief at rest measured by an analgesia consumption adjusted pain intensity on a visual analogue scale at different time points in all subgroup comparisons. Pain is measured on a visual analogue scale (VAS) while coughing. The VAS is a horizontal line (100 mm) labelled from "no pain" on the left (0 mm) to "most extreme pain experienced" on the right (100 mm).

Time frame
4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
2

Analgesia consumption

Intraoperative and postoperative analgesia consumption at different time points.

Time frame
4 and 6 hours after last suture; twice daily from day 1 to day 3 postoperative or until tube removal; on discharge home; on follow up day 30 and 180.
3

Duration of the thoracic drainage

Duration of the thoracic drainage in hours from skin closure until chest tube removal if the air flow is ≤ 20 ml/min.

Time frame
From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.
4

Fluid output

Duration of fluid output reported per 24h measured in ml/kg/24h with Medela Thopaz+™ until the chest tube is removed.

Time frame
From 2 until 6 hours after last suture; twice daily from day 1 until the chest tube is removed.

Other outcomes

Sponsors and contacts

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University Hospital, Basel, Switzerland

Lead sponsor

Source ClinicalTrials.gov
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