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

NCT ID: NCT03228056

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-12-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

pain intensity measured in VAS scale

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

pain intensity measured in VAS scale

Intervention Type: 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

• 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

Group Type: ACTIVE_COMPARATOR

pain intensity measured in VAS scale

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmonary Hospital Zakopane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcin Zieliński, PhD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Hospital, Zakopane, Poland

Locations

Pulmonary Hospital

Zakopane, Malopolska, Poland

Site Status: RECRUITING

Pulmonary Hospital

Zakopane, , Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Sylweriusz Kosiński, PhD

Role: CONTACT

kosa@mp.pl

602480289

Facility Contacts

Sylweriusz Kosiński

Role: primary

kosa@mp.pl

602480289

Sylweriusz Kosiński

Role: primary

kosa@mp.pl

602480289

Other Identifiers

PHZakopane

Identifier Type: -

Identifier Source: org_study_id