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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 20, 2020

Detailed Description

Our study will be designed to estimate and comparethe analgesic effect of single shotbilatral erector spinae plane block in pediatric patients undergoing corrective cardiac surgeries versus fentanyl infusion 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 theanesthesiologist who is expert in doing the ESPB in patients included within the block group. this expert anaesthesiologistwill not be involved in collecting data but another anaesthesia doctor will be responsible for patientmanagement and collecting the intraoperative and postoperative data.

Interventions

  • Procedure: bilateral erector spinae block
    • 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.
  • Drug: Fentanyl
    • The patient will receive continous fentanyl infusion throughout the procedure.

Arms, Groups and Cohorts

  • Active Comparator: bilateral erector spinae plane block plus fentanyl infusion
    • The patient WILL receive bilateral erector spinae plane block in addition to fentanyl infusion
  • Active Comparator: fentanyl infusion only
    • The patient will receive continous intravenous infusion of fentanyl

Clinical Trial Outcome Measures

Primary Measures

  • The total dose of intraoperative fentanyl boluses in microgram.
    • Time Frame: 3 months
    • The total dose of intraoperative fentanyl boluses in microgram

Secondary Measures

  • Pain assessment at postoperatively by FLACC score from 1 to 6
    • Time Frame: 3 months
    • Pain assessment postoperatively by FLACC score
  • Intra and postoperative SBP in mmHg
    • Time Frame: 3 months
    • Intra and postoperative SBP in mmHg
  • Intra and postoperative haemodynamics including HR in beats per minute
    • Time Frame: 3 months
    • Intra and postoperative haemodynamics including HR in beats per minute
  • Total consumption of fentanyl in microgram during the first 24 hours postoperatively.
    • Time Frame: 3 monts
    • Total consumption of fentanyl in microgram during the first 24 hours postoperatively

Participating in This Clinical Trial

Inclusion Criteria

  • Age:2 months-2years.
  • ASA, American Society of Anesthesiology, II and III .
  • Patients undergoing corrective 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).

Gender Eligibility: All

Minimum Age: 2 Months

Maximum Age: 2 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: AHMED ALI GADO, Director – Cairo University
  • Overall Contact(s)
    • Ahmed Gado, Lecturer, 01004493693, gado_shahen@yahoo.com

References

Anand VG, Kannan M, Thavamani A, Bridgit MJ. Effects of dexmedetomidine added to caudal ropivacaine in paediatric lower abdominal surgeries. Indian J Anaesth. 2011 Jul;55(4):340-6. doi: 10.4103/0019-5049.84835.

Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9.

El Shamaa HA, Ibrahim M. A comparative study of the effect of caudal dexmedetomidine versus morphine added to bupivacaine in pediatric infra-umbilical surgery. Saudi J Anaesth. 2014 Apr;8(2):155-60. doi: 10.4103/1658-354X.130677.

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Kaushal B, Chauhan S, Magoon R, Krishna NS, Saini K, Bhoi D, Bisoi AK. Efficacy of Bilateral Erector Spinae Plane Block in Management of Acute Postoperative Surgical Pain After Pediatric Cardiac Surgeries Through a Midline Sternotomy. J Cardiothorac Vasc Anesth. 2020 Apr;34(4):981-986. doi: 10.1053/j.jvca.2019.08.009. Epub 2019 Aug 12.

Muñoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26.

De la Cuadra-Fontaine JC, Concha M, Vuletin F, Arancibia H. Continuous Erector Spinae Plane block for thoracic surgery in a pediatric patient. Paediatr Anaesth. 2018 Jan;28(1):74-75. doi: 10.1111/pan.13277.

Hernandez MA, Palazzi L, Lapalma J, Forero M, Chin KJ. Erector Spinae Plane Block for Surgery of the Posterior Thoracic Wall in a Pediatric Patient. Reg Anesth Pain Med. 2018 Feb;43(2):217-219. doi: 10.1097/AAP.0000000000000716.

Ueshima H, Otake H. Clinical experiences of erector spinae plane block for children. J Clin Anesth. 2018 Feb;44:41. doi: 10.1016/j.jclinane.2017.10.021.

Kaplan I, Jiao Y, AuBuchon JD, Moore RP. Continuous Erector Spinae Plane Catheter for Analgesia After Infant Thoracotomy: A Case Report. A A Pract. 2018 Nov 1;11(9):250-252. doi: 10.1213/XAA.0000000000000799.

Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.

Merkel S, Voepel-Lewis T, Malviya S. Pain assessment in infants and young children: the FLACC scale. Am J Nurs. 2002 Oct;102(10):55-8.

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