NCT04168177

Brief Summary

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

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

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

Study Start

First participant enrolled

February 17, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

February 20, 2019

Last Update Submit

June 11, 2020

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • intraoperative anaesthetic consumption

    6 hours

Study Arms (2)

control group

ACTIVE COMPARATOR
Procedure: PCA

ESP Group

ACTIVE COMPARATOR
Procedure: ESP

Interventions

PCAPROCEDURE

Patient controlled analgesia

control group
ESPPROCEDURE

erector spinae plane block

ESP Group

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • elective surgery
  • childern between 4 and 10 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Skin TestsImmunologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImmunologic TechniquesAntigen-Antibody ReactionsImmune System Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
the data collector will be unaware of the nature of the study
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: patients will be randomly assigned into one of two groups, control group will receive patient controlled analgesia, and intervention group will receive ESP Block .
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anaesthesia and pain management

Study Record Dates

First Submitted

February 20, 2019

First Posted

November 19, 2019

Study Start

February 17, 2019

Primary Completion

July 17, 2020

Study Completion

December 20, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)