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

NCT03218098 | Completed

• 1 other identifier: 1037/2012
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Operative time reduction

  Operative time reduction in minutes

  up to 180 min

Secondary Outcomes (1)

• pain score

  up to 48 hours

Study Arms (2)

Smaller Incision

EXPERIMENTAL

UVATS access for lobectomy with small skin access 4 cm

Procedure: Lobectomy via UVATS

Traditional Incision

ACTIVE COMPARATOR

UVATS access for lobectomy with longer skin access 8 cm

Procedure: Lobectomy via UVATS

Interventions

Lobectomy via UVATS PROCEDURE

lobectomy with small skin access 4 cm

Smaller Incision; Traditional Incision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 14, 2017
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 14, 2017

Record last verified: 2017-07