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Erector Spinae Plane Block Versus Serratus Plane Block for Breast Surgery

Primary Purpose

Postoperative Pain, Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Bupivacaine Hcl 0.25% Inj

Bupivacaine HCl Inj 0.25%

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

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

Inclusion Criteria:

American Society of Anesthesiologist's physiologic state I-III patients
undergoing breast cancer surgery
18-65 years

Exclusion Criteria:

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

Sites / Locations

Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

ultrasound guided serratus plane block

ultrasound guided erector spinae plane block

Arm Description

Ultrasound Guided Serratus Plane Block 30 ml %0.25 Bupivacaine

Ultrasound Guided Erector Spinae Plane Block 20 ml %0.25 Bupivacaine

Outcomes

Primary Outcome Measures

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) at first hour postoperatively

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

NCT03538483

First Posted

May 16, 2018

Last Updated

May 9, 2019

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT03538483

Brief Title

Erector Spinae Plane Block Versus Serratus Plane Block for Breast Surgery

Official Title

Erector Spinae Plane Block Versus Serratus Plane Block on Postoperative Opioid Consumption for Modified Radical Mastectomy and Axillary Lymph Node Dissection

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

Serratus plane block (SPB) was first described in 2013 by Blanco and designed to primarily block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral anterior and posterior part of thoracic wall.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 aim of this study is to compare Serratus plane block and erector spinae plane block on postoperative pain in patients undergoing modified radical mastectomy and axillary lymph node dissection

6. Conditions and Keywords

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

Postoperative Pain, Breast Cancer

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 serratus plane block

Arm Type

Active Comparator

Arm Description

Ultrasound Guided Serratus Plane Block 30 ml %0.25 Bupivacaine

Arm Title

ultrasound guided erector spinae plane block

Arm Type

Active Comparator

Arm Description

Ultrasound Guided Erector Spinae Plane Block 20 ml %0.25 Bupivacaine

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Hcl 0.25% Inj

Intervention Description

30 ml %0,25 bupivacaine

Intervention Type

Drug

Intervention Name(s)

Bupivacaine HCl Inj 0.25%

Intervention Description

20 ml %0,25 bupivacaine

Primary Outcome Measure Information:

Title

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) at first hour postoperatively

Time Frame

postoperative first24 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

Female

Gender Based

Yes

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 breast cancer surgery 18-65 years Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases coagulopathy

Facility Information:

Facility Name

Ataturk University

City

Erzurum

ZIP/Postal Code

25100

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Erector Spinae Plane Block Versus Serratus Plane Block for Breast Surgery

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