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Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Video Assisted Thoracoscopic Surgery

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Bupivacaine Hcl 0.25% Inj

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

American Society of Anesthesiologist's physiologic state I-III patients
Undergoing video assisted thoracoscopic surgery

Exclusion Criteria:

chronic pain
bleeding disorders
renal or hepatic insufficiency
patients on chronic non-steroidal anti-inflammatory medications
emergency cases

Sites / Locations

Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ultrasound guided erector spinae plane block

ultrasound guided paravertebral block

Arm Description

ultrasound guided erector spinae plane block with 20 ml %0.25 bupivacaine

ultrasound guided paravertebral block with 20 ml %0.25 bupivacaine

Outcomes

Primary Outcome Measures

Postoperative opioid consumption

First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

Visual analog pain score

Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Block performing time

The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration

Full Information

NCT ID

NCT03538496

First Posted

May 16, 2018

Last Updated

May 9, 2019

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT03538496

Brief Title

Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Video Assisted Thoracoscopic Surgery

Official Title

Erector Spinae Plane Block Versus Thoracic Paravertebral Block on Postoperative Pain for Video Assisted Thoracoscopic Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

September 1, 2018 (Actual)

Study Completion Date

September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block for thoracic and abdominal surgery. It was first described by Forero et al. in 2016, effectiveness being reported in four cases. The paravertebral block has been successfully used in various surgical patient groups for purposes of anesthesia or postoperative pain management such as thoracotomy, breast surgery and abdominal surgery. The aim of this study is to compare the analgesic effects of erector spinae plane block and paravertebral block in patients undergoing video assisted thoracoscopic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ultrasound guided erector spinae plane block

Arm Type

Active Comparator

Arm Description

ultrasound guided erector spinae plane block with 20 ml %0.25 bupivacaine

Arm Title

ultrasound guided paravertebral block

Arm Type

Active Comparator

Arm Description

ultrasound guided paravertebral block with 20 ml %0.25 bupivacaine

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Hcl 0.25% Inj

Intervention Description

Single shot 20 ml 0.25 bupivacaine

Primary Outcome Measure Information:

Title

Postoperative opioid consumption

Description

First 24 hours total fentanyl consumption with patient controlled analgesia

Time Frame

First 24 hours

Secondary Outcome Measure Information:

Title

Visual analog pain score

Description

Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)

Time Frame

postoperative 0-24 hours

Title

Block performing time

Description

The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration

Time Frame

First hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients Undergoing video assisted thoracoscopic surgery Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Facility Information:

Facility Name

Ataturk University

City

Erzurum

ZIP/Postal Code

25100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

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Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Video Assisted Thoracoscopic Surgery

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