Erector Spinae Plane Block in Pediatric Hip Surgery

Evaluation of Post Operative Analgesia of the Erector Spinae Plane Block in Pediatric Patients Undergoing Hip Surgery: a Randomized Control Trial

Hip Surgery in pediatric patients is considered an extremely painful procedure. Managing pain in this surgery is challenging even with several available options, each with limitations. Erector spinae plane (ESP) block is a novel technique that has been used in different types of surgery, with promising results. Many case reports for use of ESPB are available in the literature but to our knowledge, no cohort studies or randomized controlled trials have been performed on ESPB for hip surgery in pediatrics age group against a traditional method as caudal block.1,2 AIM OF WORK

. The Primary outcome of this study is to compare the efficacy of analgesia resulting from the Erector spinae plane block versus the caudal block in pediatric patients undergoing hip surgery using the FLACC score and the duration of the analgesia of both methods till the first rescue analgesic.

The Secondary outcome is to compare the analgesic rescue frequency and total dose given in both groups as well as comparing the complications that might occur from each analgesic technique.

Study Overview

• Status: Unknown
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Erector spinae plane block; Procedure: caudal block

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University
    • Contact: yasser osman; Phone Number: 01006357996; Email: yasseralx@hotmail.com
    • Sub-Investigator: rbab saber, asst prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I II scheduled for hip surgery.

Exclusion Criteria:

• • Parent refusal

  • Coagulopathy
  • Patient with congenital heart disease
  • Infection at the site of puncture
  • Significant spinal anatomical anomaly
  • Patient with neuromuscular disorder
  • Any known allergy to the drug used

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP (Erector spinae block): were given general anesthesia plus Erector spinae plane block	Procedure: Erector spinae plane block; An ultrasound-guided Erector spinae plane block was performed with the patient lying on the his side and the surgical side on the top. After skin disinfection, sterile draping was be placed and the ultrasound probe was sheathed. The level of the block was the transverse process of L2. The block was performed using a 9-12 MHz linear probe (LOGIQe, GE Healthcare, USA), which was placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) was identified, and a 22 G, 50 mm insulated needle (Sonoplex Stim, Pajunk, Germany) was inserted cranio-caudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 ml/kg of 0.25% bupivacaine was injected to confirm the correct position by visualizing the solution lifting the ESM off the transverse process.
Active Comparator: GROUP (caudal block): were given general anesthesia plus caudal block	Procedure: caudal block; caudal block was performed using anatomical landmarks and ultrasound guided and confirmed with a concentration of bupivacaine of 0.25%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Pain was assessed using face, legs, activity, and cry consolability scale [FLACC] 1-10 1 is no pain and 10 is the worst pain.	1 day .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	not any complication related to the block	through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: April 12, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1234 (Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No