Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Aortic Coarcitectomy

NCT04128540 | Completed Phase 3

• 1 other identifier: MD-213-2019
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Pain is considered to be subjective, however in children it is believed to be felt rather than expressed, because they often depend on the caregiver for their safety and well-being. There is significant pain after thoracotomy surgery because of pleural and muscular damage, ribcage disruption, and intercostal nerve damage during surgery, which if not effectively managed, it will lead to various systemic complications; pulmonary (atelectasis, pneumonia, and stasis of bronchial secretions), cardiovascular (increased oxygen consumption and tachycardia), musculoskeletal (muscle weakness), increased neuro-hormonal response and prolonged hospital stay. So adequate and sufficient post-operative analgesia for paediatric patients is mandatory. The use of highly potent opioids for paediatric cardiac anaesthesia has gained widespread popularity during the last 20 years.In addition to the important advantage of hemodynamic stability, the large-dose opioid-based anaesthetic techniques also blunt the stress response, However, large doses can cause oversedation, respiratory depression, and prolonged mechanical ventilation after surgery. Erector Spinae Plane Block (ESPB), recently developed by Forero et al, is a novel technique in management of thoracic neuropathic pain guided by ultrasound. It became popular because it is much safer and easily administered than other alternative regional techniques as thoracic paravertebral and thoracic epidural block. To our knowledge, Erector Spinae Plane Block (ESPB) performed in aortic coarcitectomy operations has not been investigated yet.This has encouraged the performance of the present study.

Conditions

Aortic Coarctation; Erector Spinae Plane Block; Paediatric

Outcome Measures

Primary Outcomes (1)

• The total dose of intraoperative fentanyl boluses.

  microgram/kg

  From skin incision till 5 minutes after skin closure

Secondary Outcomes (2)

• Face, Leg, Activity, Cry, Consolability

  30 min, 60 min, 2 hours, 4hours, 8hours, 16hours and 24 hours postoperatively

• postoperative Morphine

  30 minutes postoperative till 24 hours postoperative

Study Arms (2)

Control group

OTHER

This group will receive fentanyl infusion only

Drug: Fentanyl

ESPB group

ACTIVE COMPARATOR

This group will receive fentanyl infusion plus Ultrasound guided ESPB

Drug: Fentanyl; Procedure: Erector spinae plane block

Interventions

Fentanyl DRUG

fentanyl infusion at a dose of (1 μg/kg/hour) after induction of anesthesia and to be continued all through the whole operation.rescue analgesia by a bolus of (Fentanyl 1mcg/kg) will be given to the patients in either group, if either systolic blood pressure or heart rate increased more than 20% of the baseline readings.

Control group; ESPB group

Erector spinae plane block PROCEDURE

ultrasound guided erector spinae plane block by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). This will be performed at the same side of the planned thoracotomy under strict aseptic precautions.A high frequency 12 MHz linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process. Three muscles; trapezius, rhomboids major, and erector spinae will be identified superior to the hyperechoic transverse process. Using in-plane approach a 25 G needle will be inserted in caudal-cephalic direction, until the tip is deep to erector spinae muscle. Correct needle tip location will be confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..

ESPB group

Eligibility Criteria

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

You may qualify if:

• Age: 3 months-12 months.
• A III .
• Patients undergoing aortic coarcitectomy operation undergone with Lateral thoracotomy incision.

You may not qualify if:

• Patients whose parents or legal guardians refusing to participate.
• Preoperative mechanical ventilation.
• Preoperative inotropic drug infusion.
• Patients undergoing aortic coarctectomy operation undergone with midline sternotomy incision.
• Known or suspected coagulopathy.
• Any congenital anomalies of the sacrum/the vertebral column or any infection at the site of injection.
• Known or suspected allergy to any of the studied drugs.
• Elevated liver enzymesmore than the normal values.
• Renal function impairment (Creatinine value more than 1.2mg/dl or blood urea nitrogen more than 20mg/dl).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Al-Ainy Hospital

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Aortic Coarctation

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 16, 2019
• Study Start: February 1, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: July 8, 2022

Record last verified: 2022-07

Locations

EG (1)