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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05132946
Enrollment
40
Registered
2021-11-24
Start date
2021-11-01
Completion date
2022-02-10
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief 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.

Interventions

PROCEDURENerve 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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Months to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
The number of times for usage of fentanyl in postoperative periodin the first 12 hours.

Countries

Egypt

Contacts

Primary ContactSamar MD Soliman, Lecturer
dr_sm.md@hotmail.com01006236494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026