ESPB Combined With Intercostal Nerve Block in VATs

September 20, 2019 updated by: Tae Kyong Kim, Seoul National University Hospital

Erector Spinae Plane Block Combined With Intercostal Nerve Block in Video Assisted Thoracoscopic Surgery: a Randomized Study

A randomized prospective trial to test the effect of additional Erector Spinae Plane Block (ESPB) with intercostal nerve block during video assisted thoracoscopic surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A prospective randomized trial which aims to evaluate effect of peripheral nerve block for pain management, the Erector Spinae Plane Block (ESPB) in patients undergoing video assisted thoracoscopic surgery with intercostal nerve block.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • SMG - SNU Boramae Medical Center
        • Contact:

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Wedge Resection or Lobectomy under VATS approach.

Exclusion Criteria:

  • Age < 20 years
  • Patients who has anatomical abnormality in any spine
  • Patients who has skin infection near to be the present procedure site
  • Intercostal nerve block is not performed during surgery
  • Previous lung surgery history of 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intercostal block with ESPB
Performed ESPB in VATs with intercostal nerve block
Procedure: ESPB and Intercostal nerve block
Erector spinae plane block + Intercostal nerve block
Active Comparator: Intercostal block without ESPB
Not Performed ESPB in VATs with intercostal nerve block
Procedure: Intercostal nerve block
Intercostal nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 1 hour after surgery
VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)
1 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: 6 hours after surgery
VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)
6 hours after surgery
Postoperative Pain
Time Frame: 12 hours after surgery
VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)
12 hours after surgery
Postoperative Pain
Time Frame: 24 hours after surgery
VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)
24 hours after surgery
Postoperative Pain
Time Frame: 48 hours after surgery
VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)
48 hours after surgery
Opioid consumption
Time Frame: postoperative 24 hours
cumulative total opioid consumption
postoperative 24 hours

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Tae Kyong Kim, MD, phD, SMG-SNU Boramae

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)

June 18, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 12, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-107

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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