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ESPB Combined With Intercostal Nerve Block in VATs

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ClinicalTrials.gov Identifier: NCT03949790
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Tae Kyong Kim, Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Video Assisted Thoracoscopic Surgery Procedure: ESPB and Intercostal nerve block Procedure: Intercostal nerve block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erector Spinae Plane Block Combined With Intercostal Nerve Block in Video Assisted Thoracoscopic Surgery: a Randomized Study
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020

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




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


Secondary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 6 hours after surgery ]
    VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

  2. Postoperative Pain [ Time Frame: 12 hours after surgery ]
    VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

  3. Postoperative Pain [ Time Frame: 24 hours after surgery ]
    VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

  4. Postoperative Pain [ Time Frame: 48 hours after surgery ]
    VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

  5. Opioid consumption [ Time Frame: postoperative 24 hours ]
    cumulative total opioid consumption



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949790


Contacts
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Contact: Tae Kyong Kim, Md, phD +82-2-870-2519 ktkktk@gmail.com

Locations
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Korea, Republic of
SMG - SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 07061
Contact: Tae Kyong Kim, MD    82-2-2072-2467    ktkktk@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Chair: Tae Kyong Kim, MD, phD SMG-SNU Boramae
Publications:
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Responsible Party: Tae Kyong Kim, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03949790    
Other Study ID Numbers: 2019-107
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No