Serratus Plane Block For Breast Reduction Surgery (SPB)

January 21, 2017 updated by: Ali Ahiskalioglu, Ataturk University

The Effects of Bilateral Serratus Plane Block on Postoperative Opioid Consumption After Breast Reduction Surgery

Serratus plane block 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.Increased use of ultrasound guidance for regional anesthesia in recent years has led to definition of thoracic wall PECs blocks by Blanco. The Serratus plain block (SPB), providing wider analgesia, with easier application and less adverse effects than neuroaxial blocks, has been defined after these blocks and has taken its place in the literature.In spite of the insufficient randomized clinical trials in the literature, SPB has been reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections, and the results are promising. The aim of this study is to determine effectiveness of ultrasound guided bilateral serratus plane block in patients undergoing breast reduction surgery.

Main outcome measures: The primary endpoint is postoperative opioid consumption.

Secondary endpoints are visual analogue pain scores, opioid related side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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
        • Atatürk 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 reduction surgery

Exclusion Criteria:

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasound guided serratus plane block
Bilateral ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine
Drug: Bupivacaine
30 ml %0,25 bupivacaine bilaterally
Placebo Comparator: ultrasound guided sham block
Bilateral ultrasound guided sham block with 2 ml saline subcutaneously
Drug: Saline
2 ml saline subcutaneously bilaterally

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain score
Time Frame: postoperative first hour
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 first hour
Visual analog pain score
Time Frame: postoperative second hour
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 second hour postoperatively.
postoperative second hour
Visual analog pain score
Time Frame: postoperative 4th hour
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 4th hour postoperatively.
postoperative 4th hour
Visual analog pain score
Time Frame: postoperative 12th hour
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 12th hour postoperatively.
postoperative 12th hour
Visual analog pain score
Time Frame: postoperative 24th hour
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 24th hour postoperatively.
postoperative 24th hour
Visual analog pain score
Time Frame: postoperative 8thhour
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 8th hour postoperatively.
postoperative 8thhour

Collaborators and Investigators

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

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Ali Ahiskalioglu, Ataturk University Anesthesiology and Reanimation

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

July 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimate)

October 12, 2016

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 21, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTF ANESTHESIA3

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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