NCT04918433

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

1.1 years

First QC Date

May 27, 2021

Last Update Submit

June 6, 2021

Conditions

Local Infiltration

Outcome Measures

Primary Outcomes (2)

  • Weight, height , BMI

    Weight in kg and height in cm to allow BMI measurement weight (kg) / height (m2)

    1 year

  • Postoperative pain score

    Postoperative pain score at rest, hemodynamic effects, analgesic consumption

    1 year

Study Arms (2)

TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)

ACTIVE COMPARATOR

After induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine

Procedure: Regional anaesthesia

PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)

ACTIVE COMPARATOR

After induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine

Procedure: Regional anaesthesia

Interventions

Regional anaesthesiaPROCEDURE

Regional anaesthesia for sternotomy incision for congenital cardiac surgery

PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • either sex, aged 2-12 years, undergoing
  • elective cardiac surgery via median sternotomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, 23541, Egypt

RECRUITING

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Central Study Contacts

Ibrahim Mabrouk, Phd

CONTACT

00201224336786ibrahim_wama@hotmail.com

Islam Elbardan, Phd

CONTACT

+20 111 227 8083Islamelbardan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 8, 2021

Study Start

June 1, 2021

Primary Completion

June 25, 2022

Study Completion

July 25, 2022

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)