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

Sponsor

University of Alexandria (Other)

Overall Status

Recruiting

CT.gov ID

NCT04918433

Collaborator

(none)

Enrollment

Location

Arms

13.8

Anticipated Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Local Infiltration	Procedure: Regional anaesthesia	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 25, 2022

Anticipated Study Completion Date :

Jul 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB) After induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine	Procedure: Regional anaesthesia Regional anaesthesia for sternotomy incision for congenital cardiac surgery
Active Comparator: PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB) After induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine	Procedure: Regional anaesthesia Regional anaesthesia for sternotomy incision for congenital cardiac surgery

Arm

Intervention/Treatment

Active Comparator: TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)

After induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine

Procedure: Regional anaesthesia

Regional anaesthesia for sternotomy incision for congenital cardiac surgery

Active Comparator: PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)

After induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine

Procedure: Regional anaesthesia

Regional anaesthesia for sternotomy incision for congenital cardiac surgery

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria university	Alexandria		Egypt	23541

Sponsors and Collaborators

University of Alexandria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ibrahim Mabrouk Ibrahim, Assistant lecturer, University of Alexandria

ClinicalTrials.gov Identifier:

NCT04918433

Other Study ID Numbers:

First Posted:

Jun 8, 2021

Last Update Posted:

Jun 8, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Jun 8, 2021