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

NCT05132946 | Unknown

• 1 other identifier: FAMSU R 167/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• The number of times for usage of fentanyl in postoperative period

  in the first 12 hours.

Study Arms (2)

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

ACTIVE COMPARATOR

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

Procedure: Nerve block

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

NO INTERVENTION

Interventions

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

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Samar Soliman

Cairo, Nasr City, 11511, Egypt

RECRUITING

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Samar MD Soliman, Lecturer

CONTACT

01006236494; dr_sm.md@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 24, 2021
• Study Start: November 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 10, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

EG (1)