Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy

Lung Cancer Clinical Trial

Official title:

Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03228056
• Other study ID #: PHZakopane
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2017
• Last updated: April 9, 2018
• Start date: June 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2018
• Source: Pulmonary Hospital Zakopane
• Contact: Sylweriusz Kosinski, PhD
• Phone: 602480289
• Email: kosa[@]mp.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This single-center, prospective, randomized controlled trial was designed to assess and compare the postoperative pain after VATS lobectomy performed though one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measure is cumulative morphine consumption up to 72 hours after surgery

Description:

The best VATS technique for lobectomy has not been well defined yet. Most of the authors describe the VATS approach to lobectomy via 2 to even 4 incisions. The final step in the evolution of the technique is the use of a single-port approach. If conventional multiportal VATS is superior to open thoracotomy by virtue of minimizing surgical access trauma, then further reduction in such access trauma should yield even greater benefits. Therefore, reducing the number of wounds from three or four to just one, should, in theory, lead to less pain, paresthesia, and morbidity as well as faster recovery. However, critics of the uniportal VATS approach may raise concerns about whether this most minimally invasive surgical approach for lung surgery may compromise safety and treatment efficacy. In addition, there's the concern about true invasiveness of the procedure. This prospective, randomized controlled trial was designed to compare the postoperative pain after VATS lobectomy performed through one, two and three incisions. The primary outcome measure is pain intensity measured in VAS scale. The secondary outcome measures are cumulative morphine consumption up to 72 hours after surgery in 4-hour intervals and dynamic spirometry (PEF, FEV1 and FVC) measured daily at the bedside up to 72 hours after surgery. All patients will receive the same regimen of postoperative analgesia based on thoracic epidural block, non-steroidal anti-inflammatory drugs and rescue doses of morphine in PCA system. The side effects and complications including atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiratory depression and sedation will be analysed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1-3

2. undergo videothoracoscopic lung lobectomy

3. forced expiratory volume in 1 second (FEV1) >1,5 l/min

4. no contraindications for epidural anesthesia

5. ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.

Exclusion Criteria:

1. prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.

2. during the study: failure to place epidural catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).

Related Conditions & MeSH terms

• Lung Cancer
• Pain, Postoperative

Intervention

Diagnostic Test:
• pain intensity measured in VAS scale
Pain intensity in 0-100 mm VAS scale is measured every 4 hours on standard ruler beginning from the end of the surgery.

Locations

Country	Name	City	State
Poland	Pulmonary Hospital	Zakopane	Malopolska
Poland	Pulmonary Hospital	Zakopane

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonary Hospital Zakopane

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity	0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery	up to 72 hours after the end of surgery
Secondary	opioid consumption	cumulative rescue morphine consumtion (PCA) in miligrams	up to 72 hours after the end of surgery
Secondary	rate of complications	frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)	up to 72 hours after the end of surgery