Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
Primary Purpose
Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lobectomy via UVATS
Sponsored by

About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Smaller Incision
Traditional Incision
Arm Description
UVATS access for lobectomy with small skin access 4 cm
UVATS access for lobectomy with longer skin access 8 cm
Outcomes
Primary Outcome Measures
Operative time reduction
Operative time reduction in minutes
Secondary Outcome Measures
pain score
VAS score
Full Information
NCT ID
NCT03218098
First Posted
July 5, 2017
Last Updated
July 11, 2017
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT03218098
Brief Title
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
Official Title
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smaller Incision
Arm Type
Experimental
Arm Description
UVATS access for lobectomy with small skin access 4 cm
Arm Title
Traditional Incision
Arm Type
Active Comparator
Arm Description
UVATS access for lobectomy with longer skin access 8 cm
Intervention Type
Procedure
Intervention Name(s)
Lobectomy via UVATS
Intervention Description
lobectomy with small skin access 4 cm
Primary Outcome Measure Information:
Title
Operative time reduction
Description
Operative time reduction in minutes
Time Frame
up to 180 min
Secondary Outcome Measure Information:
Title
pain score
Description
VAS score
Time Frame
up to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
12. IPD Sharing Statement
Learn more about this trial
Post-Operative Pain After Uniportal Vats Lobectomy: Does A Smaller Incision Result In Better Recovery?
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