Erector Spinae Plane Block Versus Paravertebral Block During Non-intubated Thoracoscopic Lung Resections. (PABATS)

May 5, 2022 updated by: IRCCS Sacro Cuore Don Calabria di Negrar

Pain Blocks in Awake Thoracic Surgery: A Randomized Prospective Trial to Test the Non-inferiority of Erector Spinae Plane Block (ESPB) in Comparison With Paravertebral Block During Non-intubate, Thoracoscopic Lung Resection.

A randomized prospective trial to test the non-inferiority of Erector Spinae Plane Block (ESPB) in comparison with paravertebral block during non-intubated thoracoscopic lung resection

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized trial which aims to evaluate a new technique of peripheral nerve block for pain management, the Erector Spinae Plane Block (ESPB) in patients undergoing minimally invasive lung resection in spontaneous breathing, with intravenous sedation ("non-intubated thoracic surgery"). ESPB will be compared with a largely employed procedure for loco regional pain management: the Paravertebral block (PB). Both procedures are performed under ultrasonographic guidance to allow proper visualization of the target site. Surgery is carried out by means of a minimally invasive approach (Video Assisted thoracic Surgery) with two keyhole incisions on the affected side.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

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

  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Sacro Cuore - Don Calabria 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Wedge Resection of pulmonary nodules performed with a two-portal or three-portal VATS approach.

Peripheral (within 3 cm from the surface of the inflated lung) nodules, less than 2 cm in diameter.

Acceptance of awake VATS with written informed consent

Exclusion Criteria:

Age < 18 years

Patients who are pregnant or lactating

Morbid obesity (BMI > 35 )

Inability to understand and sign the Informed consent

Proven allergy to local anesthetic drugs as required by this protocol

Expected pleural adhesions (previous thoracic trauma, previous pleuro-pulmonary infection, redo surgery on the affected side)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paravertebral block (PVB)

Intraoperative pain management

  1. Sedation

    Continuous monitoring of sedation with bispectral index. Sedation is achieved with propofol 1% (target bispectral index: 50-70), plus on-demand remifentanyl (50 mcg/ml in TCI, dose target Cet 2-8 ng/ml).

  2. Paravertebral Block

Post operative pain management

  • Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg
  • Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours, and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours
Procedure: Paravertebral Block (PVB)
PVB consists in the injection of low concentration Ropivacaine (30 ml, 0.3%) in the paravertebral space (defined by the anterior aspect of the ribs, the vertebral body and the parietal pleura. The space is identified under ultrasonographic guidance by a dedicated Anesthesiologist.
Experimental: Erector Spinae Plane Block (ESPB)

Intraoperative pain management

  1. Sedation

    Continuous monitoring of sedation with bispectral index. Sedation is achieved with propofol 1% (target bispectral index: 50-70), plus on-demand remifentanyl (50 mcg/ml in TCI, dose target Cet 2-8 ng/ml).

  2. Erector Spinae Plane Block

Post operative pain management

  • Continuous infusion of Tramadol 200 mg or Ketorolac 60 mg
  • Rescue analgesia with Morphine (0.1 mg/kg) a single time every 24 hours, and/or Tramadol 100 mg up to three times every 24 hours and/ or Ketorolac 30 mg up to three times every 24 hours
Procedure: Erector Spinae Plane Block (ESPB)
ESPB consists in the injection of low concentration Ropivacaine (30 ml, 0.3%), in the anatomical plane between the Erector Spinae muscles and deeper surface of Rhomboid muscle. The space is identified under ecographic guidance, laterally to the spinous process of T5. The diffusion of the anesthetic solution along the space can be echographically appreciated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation of systemic anesthetics during the procedure
Time Frame: 1 hour from the end of the procedure
Percentage of patients who need sedation escalation
1 hour from the end of the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain perception
Time Frame: 8, 16, 24 hours from the end of procedure
Peak pain perception in three time frames (eight hours each) starting from the end of the procedure and covering the first 24 hours after the procedure
8, 16, 24 hours from the end of procedure
Post operative pain management
Time Frame: 8, 16, 24 hours from the end of procedure
Number of extra doses of rescue analgesia during the first 24 hours after the procedure.
8, 16, 24 hours from the end of procedure

Collaborators and Investigators

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

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

February 22, 2019

Primary Completion (Actual)

November 22, 2021

Study Completion (Actual)

November 22, 2021

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHT02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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