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

NCT ID: NCT04918433

Last Updated: 2021-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-07-25

Brief Summary

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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

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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.

Conditions

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Local Infiltration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)

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

Group Type ACTIVE_COMPARATOR

Regional anaesthesia

Intervention Type PROCEDURE

Regional anaesthesia for sternotomy incision for congenital cardiac surgery

PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)

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

Group Type ACTIVE_COMPARATOR

Regional anaesthesia

Intervention Type PROCEDURE

Regional anaesthesia for sternotomy incision for congenital cardiac surgery

Interventions

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Regional anaesthesia

Regional anaesthesia for sternotomy incision for congenital cardiac surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Ibrahim Mabrouk Ibrahim

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria university

Alexandria, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ibrahim Mabrouk, Phd

Role: CONTACT

00201224336786

Islam Elbardan, Phd

Role: CONTACT

+20 111 227 8083

Facility Contacts

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Nagwa Kobea, Phd

Role: primary

+20 122 336 8233

Other Identifiers

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118

Identifier Type: -

Identifier Source: org_study_id

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