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

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Completed
CT.gov ID
NCT03218098
Collaborator
(none)
44
2
29

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lobectomy via UVATS
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Smaller Incision

UVATS access for lobectomy with small skin access 4 cm

Procedure: Lobectomy via UVATS
lobectomy with small skin access 4 cm

Active Comparator: Traditional Incision

UVATS access for lobectomy with longer skin access 8 cm

Procedure: Lobectomy via UVATS
lobectomy with small skin access 4 cm

Outcome Measures

Primary Outcome Measures

  1. Operative time reduction [up to 180 min]

    Operative time reduction in minutes

Secondary Outcome Measures

  1. pain score [up to 48 hours]

    VAS score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Roma La Sapienza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohsen Ibrahim, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT03218098
Other Study ID Numbers:
  • 1037/2012
First Posted:
Jul 14, 2017
Last Update Posted:
Jul 14, 2017
Last Verified:
Jul 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2017