Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery (ESP)

July 31, 2021 updated by: Ali Ahiskalioglu, Ataturk University

Ultrasound Guided Erector Spinae Plane Block With Two Different Volume for Open Heart Surgery: Randomized Controlled Study

The erector spine plane block is currently used in many surgeries to provide postoperative analgesia. It has also been used successfully in open-heart surgery for postoperative sternotomy pain. However, an ideal volume that will provide optimum analgesia has not yet been determined.

This study aims to compare the effects of ESP block administered in two different volumes on poststernotomy pain.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologist's physiologic state I-III patients Undergoing Open Heart 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESP 20 ml
Ultrasound-Guided erector spinae plane block with 20 ml of 0.25% bupivacaine
Procedure: Ultrasound-guided erector spinae plane block
Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine
Active Comparator: ESP 30 ml
Ultrasound-Guided erector spinae plane block with 30 ml of 0.25% bupivacaine
Procedure: Ultrasound-guided erector spinae plane block
Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue analgesia
Time Frame: Post-extubation 24 hours
Total amount of rescue analgesic
Post-extubation 24 hours

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 (Anticipated)

August 2, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

July 31, 2021

First Submitted That Met QC Criteria

July 31, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 31, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AtaturkU-AnkaraCH
  • Asli Demir (Other Identifier: Ankara City Hospital)
  • Ali Ahiskalioglu (Other Identifier: Ataturk University)

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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