Comparison of Two Regional Anaesthetic Blocks for ERAS After Congenital Cardiac Surgery

June 6, 2021 updated by: Ibrahim Mabrouk Ibrahim, University of Alexandria

Comparison of Pectointercostal Block and Transverse Thoracic Plane Block for ERAS Post Congenital Cardiac Surgery

The current study is designed to compare the perioperative analgesic efficacy of transversus thoracis plane block (TTPB) and Pecto-intercostal-fascial plane block (PIFB) in children undergoing cardiac surgery via median sternotomy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Sixty paediatric patients of either sex, aged 2-12 years, undergoing elective cardiac surgery via median sternotomy. Patients will be excluded from the current study in case of, refusal to participate, redo or urgent cardiac surgery, local infection of the skin at the site of needle puncture, allergy to bupivacaine, coagulation disorders, clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension, and when extubation is intentionally planned to be delayed. Patients will be randomly assigned to one of two equal groups, the PIF block group and TTP block group, each will include 30 patients, by a computer-generated randomization table and concealed sealed opaque envelopes.

Study Type

Interventional

Enrollment (Anticipated)

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Alexandria, Egypt, 23541
        • Recruiting
        • Alexandria University
        • Contact:

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

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • either sex, aged 2-12 years, undergoing

elective cardiac surgery via median sternotomy

Exclusion Criteria:

  • refusal to participate, redo or urgent cardiac surgery, local infection of the skin at the site of needle puncture, allergy to bupivacaine, coagulation disorders, clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)
After induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine
Procedure: Regional anaesthesia
Regional anaesthesia for sternotomy incision for congenital cardiac surgery
Active Comparator: PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)
After induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine
Procedure: Regional anaesthesia
Regional anaesthesia for sternotomy incision for congenital cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight, height , BMI
Time Frame: 1 year
Weight in kg and height in cm to allow BMI measurement weight (kg) / height (m2)
1 year
Postoperative pain score
Time Frame: 1 year
Postoperative pain score at rest, hemodynamic effects, analgesic consumption
1 year

Collaborators and Investigators

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

Sponsor

University of Alexandria

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)

June 1, 2021

Primary Completion (Anticipated)

June 25, 2022

Study Completion (Anticipated)

July 25, 2022

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

June 6, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 8, 2021

Last Update Submitted That Met QC Criteria

June 6, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118

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.

Clinical Trials on Local Infiltration

Clinical Trials on Regional anaesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe