Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery

Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery, Randomized Study

ultrasound guided erector spinae plane block will be done for childern under going midline sternotomy for cardiac surgery. It is a novel block which is suspected to give powerful analgesia, decrease anaesthetic consumption and decrease awareness on cardiac bypass

Study Overview

• Status: Unknown
• Conditions: Pain Management
• Intervention / Treatment: Procedure: PCA; Procedure: ESP

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Recruiting
    • Assiut University
    • Contact: rasha hamed, MD; Phone Number: 0882413201; Email: rashaahmed11@yahoo.nom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective surgery
• childern between 4 and 10 years

Exclusion Criteria:

• emergency
• infection at injection site
• allergy to local anaestheics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group	Procedure: PCA; Patient controlled analgesia
Active Comparator: ESP Group	Procedure: ESP; erector spinae plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue score	pain scores will be assessed by anaesthesia and ICU nurse. zero mean no pain an 10 indicate the worst pain.	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
intraoperative anaesthetic consumption	6 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2019
• Primary Completion (Anticipated): July 17, 2020
• Study Completion (Anticipated): December 20, 2020

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: November 16, 2019
• First Posted (Actual): November 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ASDF

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