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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Procedure: Lobectomy via UVATS

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time reduction	Operative time reduction in minutes	up to 180 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score	VAS score	up to 48 hours

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 11, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 1037/2012