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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04918433
Other study ID # 118
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date July 25, 2022

Study information

Verified date June 2021
Source University of Alexandria
Contact Ibrahim Mabrouk, Phd
Phone 00201224336786
Email ibrahim_wama@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 25, 2022
Est. primary completion date June 25, 2022
Accepts healthy volunteers No
Gender All
Age group 2 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Regional anaesthesia
Regional anaesthesia for sternotomy incision for congenital cardiac surgery

Locations

Country Name City State
Egypt Alexandria university Alexandria

Sponsors (1)

Lead Sponsor Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight, height , BMI Weight in kg and height in cm to allow BMI measurement weight (kg) / height (m2) 1 year
Primary Postoperative pain score Postoperative pain score at rest, hemodynamic effects, analgesic consumption 1 year
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