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

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05132946
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.3
• Patients Per Site Per Month: 12.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Procedure: Nerve block	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Ultrasound-guided Erector Spinae Plane Block: A Comparative Study to Assess Its Analgesic Efficacy in Pediatric Patients Undergoing Aortic Coarctation Repair
• Actual Study Start Date: Nov 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	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
No Intervention: • Group (C): will not receive any block.

Outcome Measures

Primary Outcome Measures

1. The number of times for usage of fentanyl in postoperative period [in the first 12 hours.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 12 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samar Soliman	Cairo	Nasr City	Egypt	11511

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: samar mohammed, Lecturer of Anesthesia, Ain Shams University
• ClinicalTrials.gov Identifier: NCT05132946
• Other Study ID Numbers: FAMSU R 167/2021
• First Posted: Nov 24, 2021
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Aortic Coarctation

Study Results

No Results Posted as of Nov 24, 2021