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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
pain intensity measured in VAS scale
Sponsored by
Pulmonary Hospital Zakopane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer focused on measuring postoperative pain, videothoracoscopic surgery, thoracic epidural analgesia, lung lobectomy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Pulmonary HospitalRecruiting
  • Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

uniportal VATS lobectomy

two-ports VATS lobectomy

three-ports VATS lobectomy

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

pain intensity
0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery

Secondary Outcome Measures

opioid consumption
cumulative rescue morphine consumtion (PCA) in miligrams
rate of complications
frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)

Full Information

First Posted
June 9, 2017
Last Updated
April 9, 2018
Sponsor
Pulmonary Hospital Zakopane
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1. Study Identification

Unique Protocol Identification Number
NCT03228056
Brief Title
Postoperative Pain After Single Port, Two Ports and Three Ports VATS Lobectomy
Official Title
Postoperative Pain After Single Port, Two Ports and Three Ports Video-assisted Thoracic Surgery Lobectomy in Cancer Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pulmonary Hospital Zakopane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
postoperative pain, videothoracoscopic surgery, thoracic epidural analgesia, lung lobectomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uniportal VATS lobectomy
Arm Type
Experimental
Arm Description
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
Arm Title
two-ports VATS lobectomy
Arm Type
Active Comparator
Arm Description
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
Arm Title
three-ports VATS lobectomy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
pain intensity measured in VAS scale
Intervention Description
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 Measure Information:
Title
pain intensity
Description
0-100 mm VAS scale measured every 4 hours on standard ruler beginning from the end of the surgery
Time Frame
up to 72 hours after the end of surgery
Secondary Outcome Measure Information:
Title
opioid consumption
Description
cumulative rescue morphine consumtion (PCA) in miligrams
Time Frame
up to 72 hours after the end of surgery
Title
rate of complications
Description
frequency of postoperative complications (atelectasis, pneumonia, atrial fibrillation, urine retention, hypotension, respiatory depression, sedation)
Time Frame
up to 72 hours after the end of surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status 1-3 undergo videothoracoscopic lung lobectomy forced expiratory volume in 1 second (FEV1) >1,5 l/min no contraindications for epidural anesthesia ability to comprehend principles of VAS pain examination method and to communicate in accordance with them. Exclusion Criteria: 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. 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylweriusz Kosiński, PhD
Phone
602480289
Email
kosa@mp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Zieliński, PhD
Organizational Affiliation
Pulmonary Hospital, Zakopane, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Hospital
City
Zakopane
State/Province
Malopolska
ZIP/Postal Code
34-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylweriusz Kosiński
Phone
602480289
Email
kosa@mp.pl
Facility Name
Pulmonary Hospital
City
Zakopane
ZIP/Postal Code
34-500
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylweriusz Kosiński
Phone
602480289
Email
kosa@mp.pl

12. IPD Sharing Statement

Plan to Share IPD
No

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

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