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

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

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

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: pain intensity measured in VAS scale

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Zakopane, Poland, 34-500
    • Recruiting
    • Pulmonary Hospital
    • Contact: Sylweriusz Kosiński; Phone Number: 602480289; Email: kosa@mp.pl
  • Malopolska
    • Zakopane, Malopolska, Poland, 34-500
      • Recruiting
      • Pulmonary Hospital
      • Contact: Sylweriusz Kosiński; Phone Number: 602480289; Email: kosa@mp.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: uniportal VATS lobectomy; uniportal VATS lobectomy; thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour); ketoprofene 100 mg i.v every 12 hours; paracetamol 1000 mg i.v every 8 hours; rescue doses of morphine in PCA system (bolus dose 2 mg i.v); pain intensity measured in VAS scale	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.
Active Comparator: two-ports VATS lobectomy; two-ports VATS lobectomy; thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour); ketoprofene 100 mg i.v every 12 hours; paracetamol 1000 mg i.v every 8 hours; rescue doses of morphine in PCA system (bolus dose 2 mg i.v); pain intensity measured in VAS scale	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.
Active Comparator: three-ports VATS lobectomy; three-ports VATS lobectomy; thoracic epidural block (0.125% bupivacaine with epinephrine 1:50000, continuous infusion 3-4 ml/hour); ketoprofene 100 mg i.v every 12 hours; paracetamol 1000 mg i.v every 8 hours; rescue doses of morphine in PCA system (bolus dose 2 mg i.v); pain intensity measured in VAS scale	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
opioid consumption	cumulative rescue morphine consumtion (PCA) in miligrams	up to 72 hours after the end of surgery
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

Collaborators and Investigators

• Sponsor: Pulmonary Hospital Zakopane
• Investigators: Principal Investigator: Marcin Zieliński, PhD, Pulmonary Hospital, Zakopane, Poland

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: postoperative pain; thoracic epidural analgesia; lung lobectomy; videothoracoscopic surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PHZakopane

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No