Comparison of Efficacy of Paravertebral and Epidural Analgesia After Videothoracoscopic Lung Lobectomy

June 9, 2017 updated by: Pulmonary Hospital Zakopane

Comparison of Continuous Epidural and Continuous Paravertebral Blockade in Postoperative Analgesia After Videothoracoscopic Lung Lobectomy

Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. In traditional thoracotomy epidural anesthesia remains a golden standard. Epidural anesthesia however demands high skills to be performed correctly and presents an increased risk of grave complications. In videothoracoscopic (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single site study to test the hypothesis, that continuous paravertebral blockade is as efficient in postoperative pain reduction as continuous epidural blockade and possesses a higher safety profile.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Zakopane, Poland, 34-500
        • Pulmonary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (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 and paravertebral nerve blockade
  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 or paravertebral 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Continuous Thoracic Paravertebral Block
  1. continuous thoracic paravertebral blockade 0,08 ml/kg/h with bupivacaine 0,25% + epinephrine 1:200.000
  2. patient-controlled analgesia (morphine), bolus dose 2 mg, lockout time 10 min
Procedure: Continuous Thoracic Paravertebral Block
Before anesthesia, continuous thoracic paravertebral block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (normal saline). After injection of 5-10 ml of normal saline a catheter is advanced medially ca. 5 cm. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 20 ml bolus is injected, followed by an infusion of the same mixture at 0,08 ml/kg/h for postoperative pain management
Procedure: Patient-Controlled Analgesia with Morphine

Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:

  • patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min)
  • paracetamol 1000 mg iv every 8 hrs
  • ketoprofen 100 mg iv every 12 hrs
Experimental: Continuous Thoracic Epidural Analgesia
  1. continuous thoracic epidural block 0,06 ml/kg/h with bupivacaine 0,25% + epinephrine 1:200.000
  2. patient-controlled analgesia (morphine), bolus dose 2 mg, lockout time 10 min
Procedure: Patient-Controlled Analgesia with Morphine

Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:

  • patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min)
  • paracetamol 1000 mg iv every 8 hrs
  • ketoprofen 100 mg iv every 12 hrs
Procedure: Continuous Thoracic Epidural Block
Before anesthesia, continuous thoracic epidural block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (air). A catheter is advanced ca. 3-5 cm, and test dose with 2 ml of lidocaine 2% i injected. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 6 ml bolus is injected, followed by an infusion of the same mixture at 0,06 ml/kg/h for postoperative pain management.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
pain intensity measured in VAS in predetermined time intervals after the operation
Time Frame: up to 96 hrs after the surgery
up to 96 hrs after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)
Time Frame: up to 96 hrs after the surgery
up to 96 hrs after the surgery
frequency of side effects of regional anesthesia: urine retention resulting in necessity of bladder catheterization, hypotension, respiratory depression
Time Frame: up to 96 hrs after surgery
up to 96 hrs after surgery
frequency of respiratory complications: atelectasis or pneumonia
Time Frame: up to 96 hrs after surgery
up to 96 hrs after surgery
cumulative opioid (morphine) consumption
Time Frame: up to 96 hrs after surgery
up to 96 hrs after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pulmonary Hospital Zakopane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1/2014

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