NCT06958848

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 invasive pulmonary lobectomy and/or segmentectomy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
May 2025Aug 2027

First Submitted

Initial submission to the registry

April 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 17, 2025

Last Update Submit

April 30, 2026

Conditions

PneumothoraxPleural Effusion

Keywords

Lung SurgeryChest DrainageMinimally Invasive Thoracoscopic LobectomyMinimally Invasive Thoracoscopic Segmentectomy

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

  • 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).

    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 (11)

  • Postoperative acute pain relief at rest

    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.

  • Analgesia consumption

    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.

  • Duration of the thoracic drainage

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

  • Fluid output

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

  • Length of hospital stay

    Patients are discharged from hospital on the 3rd to 7th day, or stay up to the 10th day in case of prolonged air leak or re-operation.

  • +6 more secondary outcomes

Study Arms (4)

16F - early removal

EXPERIMENTAL

small-bore (16F) chest tubes, removal 2h until 6h after end of skin closure

Device: 16 F chest tubeProcedure: Early removal

16F - standard removal

EXPERIMENTAL

small-bore (16F) chest tubes, removal 1 day postoperative

Device: 16 F chest tubeProcedure: Standard removal

24F - early removal

EXPERIMENTAL

large-bore (24F) chest tubes, removal 2h until 6h after end of skin closure

Device: 24 F chest tubeProcedure: Early removal

24F - standard removal

ACTIVE COMPARATOR

large-bore (24F) chest tubes, removal 1 day postoperative

Device: 24 F chest tubeProcedure: Standard removal

Interventions

16 F chest tubeDEVICE

Insertion of 16F chest tube

Also known as: Small-bore chest tube
16F - early removal16F - standard removal
24 F chest tubeDEVICE

Insertion of 24F chest tube

Also known as: Large-bore chest tube
24F - early removal24F - standard removal
Early removalPROCEDURE

Removal 2-6h after end of skin closure

16F - early removal24F - early removal
Standard removalPROCEDURE

Removal 1day postoperative

16F - standard removal24F - standard removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed Consent signed by the patient (all sex and gender)
  • 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.
  • Minimally invasive anatomical lung resections under general anaesthesia: lobectomy, lobectomy with wedge resection, lobectomy combined with segmentectomy, segmentectomy with wedge resection, bilobectomy

You may not qualify if:

  • 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
  • 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
  • Not consolidated 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

PneumothoraxPleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Didier Lardinois, MD

    University Hospital, Basel, Switzerland

    STUDY CHAIR

  • Makhmudbek Mallaev, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helga Bachmann, MSc Clinical Research

CONTACT

+41 (0)61 328 71 70helga.bachmann@usb.ch

Makhmudbek Mallaev, MD

CONTACT

+41 (0)61 556 51 89makhmudbek.mallaev@usb.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

May 6, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

CH(1)