Erector Spinae Plane Block Versus Serratus Plane Block for Breast Surgery

May 9, 2019 updated by: Ali Ahiskalioglu, Ataturk University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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

  • Turkey
      • Erzurum, Turkey, 25100
        • Ataturk University

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasound guided serratus plane block
Ultrasound Guided Serratus Plane Block 30 ml %0.25 Bupivacaine
Drug: Bupivacaine Hcl 0.25% Inj
30 ml %0,25 bupivacaine
Active Comparator: ultrasound guided erector spinae plane block
Ultrasound Guided Erector Spinae Plane Block 20 ml %0.25 Bupivacaine
Drug: Bupivacaine HCl Inj 0.25%
20 ml %0,25 bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: First 24 hours
First 24 hours total fentanyl consumption with patient controlled analgesia
First 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain score
Time Frame: postoperative first24 hours
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
postoperative first24 hours
Block Performing Time
Time Frame: First hour
The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration
First hour

Collaborators and Investigators

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

Sponsor

Ataturk University

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)

December 1, 2017

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

May 16, 2018

First Submitted That Met QC Criteria

May 16, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTFANESTHESIA

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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