NCT05552417

Brief Summary

This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound-guided bilateral pectointercostal facial block in children undergoing cardiac surgery via midline sternotomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

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

September 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 23, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

September 20, 2022

Last Update Submit

May 22, 2024

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain score

    Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale ( Each category is scored on a 0-2 scale, which results in a total score of 0-10 0:comfortable,1-3:Mild discomfort,4-6:Moderate discomfort, \&7-10:Sever discomfort ) (FLACC) scale pain score at 4 hours.

    At 4 hours.

Study Arms (2)

control group

NO INTERVENTION

Conventional control group(C) (n=--) where --- children will not receive any intervention.

Pectointercostal

ACTIVE COMPARATOR

Pectointercostal facial group (PI) (n=--) where --children will have bilateral Pectointercostal Block.

Other: Pectointercostal facial plan block

Interventions

Pectointercostal facial plan blockOTHER

Pectointercostal facial group (PI) (n=--) where --children will have bilateral Pectointercostal Block.

Also known as: Pectointercostal facial nerve block
Pectointercostal

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 6 to 36 months
  • sex both
  • Weight \> 5kg
  • Pathology A-V canal , ASD closure, VSD closure surgery through a midline sternotomy.

You may not qualify if:

  • Redo patient.
  • History of allergic reactions to local anesthetics.
  • Bleeding disorders with INR \> 1.5 and/or platelets \< 50 000.
  • Rash or signs of infection at the injection site.
  • Emergency procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasralainy Faculty of Medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, ICU and Pain managment

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 23, 2022

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 1, 2024

Last Updated

May 23, 2024

Record last verified: 2024-05

Locations

EG(1)