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

Not Applicable

• Conditions: Local Infiltration
• Interventions: Procedure: Regional anaesthesia

• Registration Number: NCT04918433
• Lead Sponsor: University of Alexandria

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-27
• Status Verified: 2021-06
• Study Start: 2021-06-01
• Study First Submitted QC: 2021-06-06
• Last Update Submitted: 2021-06-06
• Study First Posted: 2021-06-08
• Last Update Posted: 2021-06-08
• Primary Completion: 2022-06-25
• Study Completion: 2022-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)	Regional anaesthesia	After induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine
PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)	Regional anaesthesia	After induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine

Primary Outcome Measures

Name	Time	Method
Weight, height , BMI	1 year	Weight in kg and height in cm to allow BMI measurement weight (kg) / height (m2)
Postoperative pain score	1 year	Postoperative pain score at rest, hemodynamic effects, analgesic consumption

Trial Locations

Locations (1)

Alexandria university; 🇪🇬 Alexandria, Egypt