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Completed

NCT Number: NCT03218098

Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?

Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?

Postoperative pain control remains one of the most common problems after major lung resection. Pain is considered a major independent factor responsible for increased perioperative morbidity and mortality: in particular, in patients with preoperative compromised clinical conditions. In fact, acute pain may compromise the patient's mobilization and the secretion's clearance with secondary possible bronchial obstruction and parenchymal lung infection.

Today, the treatment of postoperative pain after lung resection is based on association of the pharmacological therapy, including systemic use of opioids and non-steroid drugs, epidural analgesia, intercostal nerve block and cryoanalgesia with the minimally invasive surgery, like use of mini-thoracotomy, a thoracoscopic approach or intercostal nerve protection with the use of muscle sparing. In the literature, reduced tissue damage consequent to the use of limited surgical approaches is reported to be significantly effective in decreasing early postoperative pain. Thus, the use of a minimally invasive surgery for lung resections has proved to produce more tolerable pain and allow quicker functional recovery and lower postoperative complications. The aim of this prospective randomized study was to evaluate the equivalency of a smaller incision (4 cm) when compared to a longer length (8 cm) of incision performing uniportal VATS lobectomy in terms of postoperative pain results. Primarily, to evaluate the differences of operative time between the groups.

Secondly, to investigate the differences of pain scores between the two groups and the impact of pain reduction on functional results.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be aged ≥ 18 years (of either gender)
  • have provided written informed consent prior to participation in the study
  • undergoing to major lung surgery with an Uniportal VideoThoracocopic Access (UVATS).

Exclusion criteria

  • rethoracotomy
  • presence of pleural adhesions
  • Neuropathy
  • be a participant in another interventional clinical trial or have received another investigational device or device within the last 30 days (donation of excised tissue [lung or parts of lymph nodes] for biological research may occur in the same patients)

Treatment and study plan

Lobectomy via UVATS

Procedure

lobectomy with small skin access 4 cm

Primary outcomes

  1. Operative time reduction

    Time frame: up to 180 min

    Operative time reduction in minutes

Secondary outcomes

  1. pain score

    Time frame: up to 48 hours

    VAS score

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2017
Registry last updated
Jul 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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