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

Local Infiltration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04918433
• Other study ID #: 118
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Local Infiltration

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