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

NCT04452656 | Completed DMC

• 1 other identifier: N159-2020
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Local; Analgesia

Keywords

Erector spinae plane block; Pediatric; sternotomy

Outcome Measures

Primary Outcomes (1)

• The total dose of intraoperative fentanyl boluses in microgram.

  The total dose of intraoperative fentanyl boluses in microgram

  3 months

Secondary Outcomes (3)

• Pain assessment at postoperatively by FLACC score

  3 months

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

  3 monts

• extubation time

  3 months

Study Arms (2)

bilateral erector spinae plane block

ACTIVE COMPARATOR

The patient WILL receive bilateral erector spinae plane block.

Procedure: bilateral erector spinae block

NO BLOCK

NO INTERVENTION

The patient will not receive Erector spinae plane block

Interventions

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.

bilateral erector spinae plane block

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

Related Publications (12)

• 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.

  PMID: 22013248 BACKGROUND

• 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. doi: 10.1056/NEJM199201023260101.

  PMID: 1530752 BACKGROUND

• 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.

  PMID: 24843324 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 31515190 BACKGROUND

• Munoz 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. No abstract available.

  PMID: 28447318 BACKGROUND

• 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. No abstract available.

  PMID: 29226529 BACKGROUND

• 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.

  PMID: 29278605 BACKGROUND

• Ueshima H, Otake H. RETRACTED: Clinical experiences of erector spinae plane block for children. J Clin Anesth. 2018 Feb;44:41. doi: 10.1016/j.jclinane.2017.10.021. No abstract available.

  PMID: 29100022 BACKGROUND

• 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.

  PMID: 29794802 BACKGROUND

• 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.

  PMID: 29341379 BACKGROUND

• 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. doi: 10.1097/00000446-200210000-00024. No abstract available.

  PMID: 12394307 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blindness will be achieved by patient codes which will be placed into sequentially numbered sealed opaque envelopes by a research assistant who is not involved in the study. A physician not involved in patient management will be responsible for opening the envelope and give the instructions contained within each envelope to the anaesthesiologist who is expert in doing the Erector spinae plane block in patients included within the block group. This expert anaesthesiologist will not be involved in collecting data but another anaesthesia doctor will be responsible for patient management and collecting the intraoperative and postoperative data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: July 20, 2020
• Primary Completion: August 5, 2021
• Study Completion: August 15, 2021
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)