Erector Spinae Plane Block in Cardiac Surgery

June 22, 2019 updated by: Rasha Hamed, Assiut University

Ultrasound Guided Erector Spinae Plane Block in Cardiac Surgery

ultrasound guided bilateral erector spinae plane block will be used as adjuvant to general anaesthesia in cardiac surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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

  • Egypt
      • Asyut, Egypt, 71111
        • Recruiting
        • Faculty of Medicine

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective surgery

Exclusion Criteria:

  • emergency
  • patient refusal
  • infection at or near catheter insertion

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: group A
opioid analgesia
Procedure: opioid analgesia
opioid analgesia will be used with general anaesthesia
Active Comparator: group B
ESP block
Procedure: ESP block
ultrasound guided ESP Block before anaesthesia induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: 48 hours
NRS will be used to assess pain
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anaesthesia consumption
Time Frame: 6 hours
cumulative anaesthesia MAC
6 hours
ultrasound guided postoperative diaphragmatic excursion
Time Frame: 24 hours
diaphragmatic movement during inspiration an expiration
24 hours
spirometric respiratory funtion
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Assiut 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)

February 15, 2019

Primary Completion (Anticipated)

November 15, 2020

Study Completion (Anticipated)

December 15, 2020

Study Registration Dates

First Submitted

February 20, 2019

First Submitted That Met QC Criteria

June 22, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 22, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FXLD

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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