Ultrasound-Guided Serratus and Transversus Thoracic Muscle Plane Block Vs. Erector Spinae Plane Block for Acute Poststernotomy Pain

October 1, 2024 updated by: Muhammed E Aydin, Ataturk University

Comparison of Ultrasound-Guided Serratus Anterior and Transversus Thoracic Muscle Plane Block Combination Versus Erector Spinae Plane Block for Acute Poststernotomy Pain Management After Cardiac Surgery

Poststernotomy pain represents a complication that can arise following cardiac surgery. Inadequately managed pain has been linked to various adverse outcomes, including myocardial ischemia, cardiac arrhythmias, heightened coagulation tendencies, pulmonary complications, and elevated incidences of delirium and wound infections.

The Erector Spinae Plane (ESP) block, Serratus Anterior Plane (SAP) block, and Transverse Thoracic Muscle Plane (TTMP) block are demonstrated as effective regional anesthesia techniques for sternotomy pain. While these blocks differ in ease of application and efficacy, the optimal analgesic approach for cardiac surgery remains unclear. The aim of this study is to compare the analgesic efficacy of ultrasound-guided SAP and TTMP blocks combination versus ESP block administered alone in patients undergoing open heart surgery.

Study Overview

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

      • Erzurum, Turkey
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Cardiac Surgery with median sternotomy (valvular and coronary surgeries)

Exclusion Criteria:

  • Minimal invasive cardiac surgeries
  • Revision surgeries (during postoperative 48 hours)
  • Redo cardiac surgeries
  • Any contraindications for regional anesthesia technique (any allergies for local anesthetics)
  • Preoperative chronic opioid usage

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block
ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with %0.25 bupivacaine
ultrasound guided transverse thoracic muscle plane block and serratus anterior plane block will be performed with 0.25% bupivacaine
Active Comparator: ultrasound guided erector spinae plane block
ultrasound guided erector spinae plane block will be performed with 0.25% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: Postoperative 48 hours
postoperative opioid consumption will be recorded for 48 hours
Postoperative 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Visual Analog Scale
Time Frame: Postoperative 48 hours
Postoperative Visual Analog Scale assessment will be performed
Postoperative 48 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Muhammet Enes Aydin, Associate professor

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.

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)

September 1, 2023

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATATURK-Cardiovascular

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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