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Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair

NCT ID: NCT05132946

Last Updated: 2021-11-24

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-02-10

Brief Summary

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The study will include 40 patients who fulfil all the points in the inclusion and exclusion criteria will be randomized into two equal groups, each consisting of 20 patients, namely group (B) and group (C).

* Group (B): will receive erector spinae plane block.
* Group (C): will not receive any block. Postoperative pain score will be assessed using the FLACC scale or Face, Legs, Activity, Cry, Consolability scale immediately after extubation and at 1, 2, 4, 6, 8, 12, 18, and 24 hours. Routine postoperative analgesia in the form of intravenous paracetamol 7.5 mg/kg/6 hours will be given to all patients (the first dose is given after skin closure). Rescue analgesia in the form of 1 ug/kg fentanyl intravenously for patients if FLACC scale \> 4, and the time for the first rescue analgesic administration will be recorded.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group (B): will receive erector spinae plane block.

unilateral ultrasound-guided erector spinae plane block using bupivacaine 0.25% (on the left side) with total volume 0.5 ml/kg and a maximum dose of 2 mg/kg of bupivacaine in erector spinae plane block group patients

Group Type ACTIVE_COMPARATOR

Nerve block

Intervention Type PROCEDURE

unilateral ultrasound-guided erector spinae plane block using bupivacaine 0.25% (on the left side) with total volume 0.5 ml/kg and a maximum dose of 2 mg/kg of bupivacaine in erector spinae plane block group patients

• Group (C): will not receive any block.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nerve block

unilateral ultrasound-guided erector spinae plane block using bupivacaine 0.25% (on the left side) with total volume 0.5 ml/kg and a maximum dose of 2 mg/kg of bupivacaine in erector spinae plane block group patients

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All pediatric patients presented for aortic coarctation repair via left thoracotomy.

Exclusion Criteria

Hypersensitivity to local anesthetic.

* Mental or neurologic disorders.
* Preoperative critically ill patients.
* Parents or legal guardian refusal.
* Infection at the site of injection.
* Any liver disease.
* Any coagulopathy.
Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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samar mohammed

Lecturer of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samar Soliman

Cairo, Nasr City, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Samar MD Soliman, Lecturer

Role: CONTACT

Phone: 01006236494

Email: [email protected]

Facility Contacts

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Samar Soliman

Role: primary

Other Identifiers

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FAMSU R 167/2021

Identifier Type: -

Identifier Source: org_study_id