Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy

Lung Cancer Clinical Trial

Official title: Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measure is cumulative morphine consumption up to 72 hours after surgery

Clinical Trial Description

The best VATS technique for lobectomy has not been well defined yet. Most of the authors describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the evolution of the technique is the use of a single-port approach. If conventional multiportal VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then further reduction in such access trauma should yield even greater benefits. Therefore, reducing the number of wounds from three or four to just one, should, in theory, lead to less pain, paresthesia, and morbidity as well as faster recovery. However, critics of the uniportal VATS approach may raise concerns about whether this most minimally invasive surgical approach for lung surgery may compromise safety and treatment efficacy. In addition, there's the concern about true invasiveness of the procedure. This prospective, randomized controlled trial was designed to compare the postoperative pain after VATS lobectomy performed through one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC) measured daily at the bedside up to 72 hours after surgery. All patients will receive the same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and complications including atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiratory depression and sedation will be analysed. ;

Related Conditions & MeSH terms

• Lung Cancer
• Pain, Postoperative

• NCT number: NCT03228056
• Study type: Interventional
• Source: Pulmonary Hospital Zakopane
• Contact: Sylweriusz Kosinski, PhD
• Phone: 602480289
• Email: kosa@mp.pl
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2016
• Completion date: December 31, 2018