Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03228056
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Pulmonary Hospital Zakopane

Brief 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

Condition or disease Intervention/treatment Phase
Lung Cancer Diagnostic Test: pain intensity measured in VAS scale Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial
Actual Study Start Date : June 1, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. pain intensity [ Time Frame: up to 72 hours after the end of surgery ]
    0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery


Secondary Outcome Measures :
  1. opioid consumption [ Time Frame: up to 72 hours after the end of surgery ]
    cumulative rescue morphine consumtion (PCA) in miligrams

  2. rate of complications [ Time Frame: up to 72 hours after the end of surgery ]
    frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228056


Contacts
Layout table for location contacts
Contact: Sylweriusz Kosiński, PhD 602480289 kosa@mp.pl

Locations
Layout table for location information
Poland
Pulmonary Hospital Recruiting
Zakopane, Malopolska, Poland, 34-500
Contact: Sylweriusz Kosiński    602480289    kosa@mp.pl   
Pulmonary Hospital Recruiting
Zakopane, Poland, 34-500
Contact: Sylweriusz Kosiński    602480289    kosa@mp.pl   
Sponsors and Collaborators
Pulmonary Hospital Zakopane
Investigators
Layout table for investigator information
Principal Investigator: Marcin Zieliński, PhD Pulmonary Hospital, Zakopane, Poland

Layout table for additonal information
Responsible Party: Pulmonary Hospital Zakopane
ClinicalTrials.gov Identifier: NCT03228056     History of Changes
Other Study ID Numbers: PHZakopane
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pulmonary Hospital Zakopane:
postoperative pain
videothoracoscopic surgery
thoracic epidural analgesia
lung lobectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms