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NCT05132946 Clinical Trial

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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05132946
Other study ID # FAMSU R 167/2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date February 10, 2022

Study information
Verified date November 2021
Source Ain Shams University
Contact Samar MD Soliman, Lecturer
Phone 01006236494
Email dr_sm.md@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date February 10, 2022
Est. primary completion date February 1, 2022
Accepts healthy volunteers No
Gender All
Age group 3 Months to 12 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 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

Locations
Country Name City State
Egypt Samar Soliman Cairo Nasr City

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of times for usage of fentanyl in postoperative period in the first 12 hours.
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