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NCT Number: NCT04452656

Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block in Pediatric.

This randomized, double-blinded, study aims to compare the efficacy of analgesia and any side effects of U/S guided bilateral Erector SpinaePlane block versus non-block t paediatric patients undergoing corrective cardiac surgeries.

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Key information

Conditions

Anesthesia, Local Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Hospitals

Cairo, Egypt

About this study

Our study will be designed to estimate and compare the analgesic effect of single shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac surgeries versus non-block as the control group. Our primary outcome will be the total dose of intraoperative fentanyl boluses.

Randomization will be achieved by using an online random number generator. Patient codes will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A medical personnel not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anesthesiologist who is expert in doing the ESP block in patients included within the block group. The anesthesia team who managed the patients intraoperatively did not share in recording data for the research. However, another physcian will be responsible for recording the intraoperative data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age:6 months-7 years.
  • ASA, American Society of Anesthesiology, II and III .
  • Patients undergoing cardiac surgeries with midline sternotomy incision.

Exclusion criteria

  • Patients whose parents or legal guardians refusing to participate.
  • Preoperative mechanical ventilation.
  • Preoperative inotropic drug infusion.
  • 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 enzymes more than the normal values.
  • Renal function impairment (Creatinine value more than 1.2 mg/dl or BUN more than 20mg/dl).

Treatment and study plan

bilateral erector spinae block

Procedure

An 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-cephalad direction, until the tip is deep to erector spinae muscle.

Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..

0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12.

Primary outcomes

  1. The total dose of intraoperative fentanyl boluses in microgram.

    Time frame: 3 months

    The total dose of intraoperative fentanyl boluses in microgram

Secondary outcomes

  1. Pain assessment at postoperatively by FLACC score

    Time frame: 3 months

    Pain assessment postoperatively by FLACC score

  2. Total consumption of morphine during the first 24 hours postoperatively.

    Time frame: 3 monts

    Total consumption of morphine during the first 24 hours postoperatively

  3. extubation time

    Time frame: 3 months

    time from finishing skin incision suturing and cessation of anesthesia to successful removal of endotracheal tube.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Analgesic Efficacy of Ultrasound Guided Bilateral Erector Spinae Plane Block Versus Fentanyl Infusion in Pediatric Patients Undergoing Cardiac Surgeries. a Randomized Controlled Study.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2020
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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