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

NCT03228056 | Unknown

• 1 other identifier: PHZakopane
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Conditions

Lung Cancer

Keywords

postoperative pain; videothoracoscopic surgery; thoracic epidural analgesia; lung lobectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• opioid consumption

  up to 72 hours after the end of surgery

• rate of complications

  up to 72 hours after the end of surgery

Study Arms (3)

uniportal VATS lobectomy

EXPERIMENTAL

* 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

two-ports VATS lobectomy

ACTIVE COMPARATOR

* 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

three-ports VATS lobectomy

ACTIVE COMPARATOR

* 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

Interventions

pain intensity measured in VAS scale DIAGNOSTIC_TEST

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

three-ports VATS lobectomy; two-ports VATS lobectomy; uniportal VATS lobectomy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pulmonary Hospital Zakopane: lead

Study Sites (2)

Pulmonary Hospital

Zakopane, Malopolska, 34-500, Poland

RECRUITING

Pulmonary Hospital

Zakopane, 34-500, Poland

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marcin Zieliński, PhD

  Pulmonary Hospital, Zakopane, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylweriusz Kosiński, PhD

CONTACT

602480289; kosa@mp.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: July 24, 2017
• Study Start: June 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)