Actively Recruiting

Phase 4
Age: 10Years - 18Years
All Genders
ID06789029

The Effect of Dexamethasone Administration Route and Local Anesthetic Concentration on Pain, Inflammatory Response, and Neuromonitoring in Children Undergoing Scoliosis Correction

Led by Poznan University of Medical Sciences · Updated on 2026-05-22

60

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Scoliosis correction surgery in children is a complex procedure with risks such as postoperative pain, inflammation, and possible neurological complications. Effective pain management and reducing inflammation are important for faster recovery and better outcomes. Dexamethasone is often used alongside regional anesthesia because of its anti-inflammatory effects and ability to extend pain relief. This study compares different ways of giving dexamethasone (intravenous versus perineural) and local anesthetic concentrations to find the best approach for pain control, inflammation, and nerve monitoring during surgery in children. The study evaluates two treatment approaches: Erector Spinae Plane Block with 0.2% ropivacaine combined either with perineural dexamethasone at 0.1 mg/kg or intravenous dexamethasone at the same dose. The study is randomized and quadruple-masked to compare these interventions during scoliosis surgery in children aged 10 to 18 years. Researchers will observe the effects of these techniques on pain, inflammatory markers, and neuromonitoring parameters throughout the surgical and postoperative periods. Participants will be closely monitored with assessments including the time until first rescue opioid use within 48 hours after surgery, pain scores at multiple time points after surgery, intraoperative drug requirements, neuromonitoring signals, and inflammatory response markers like neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios. The study aims to optimize anesthesia protocols to improve safety and recovery after pediatric scoliosis surgery. Total participation includes surgery and follow-up assessments up to 48 hours postoperatively.

CONDITIONS

Brief Title

The Effect of Dexamethasone Administration Route and Local Anesthetic Concentration on Pain, Inflammatory Response, and Neuromonitoring in Children Undergoing Scoliosis Correction

Who Can Participate

Age: 10Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Older than 10 years and younger than 18 years
  • Scheduled for idiopathic scoliosis surgery
Not Eligible

You will not qualify if you...

  • Infection at the site of the regional anesthesia block
  • Blood clotting disorders
  • Immunodeficiency
  • American Society of Anesthesiologists (ASA) physical status of IV or higher
  • History of regular steroid medication

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and up to 48 hours after surgery

Participants undergo scoliosis correction surgery with administration of dexamethasone via different routes as part of regional anesthesia, followed by immediate post-operative monitoring of pain, inflammatory response, and neuromonitoring parameters.

1 surgery day visit and multiple assessments during 48 hours post-surgery

Trial Site Locations

Total: 1 location

1

Poznan University of Medical Sciences

Poznan, Poland, 60-701

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Research Team

M

Malgorzata Reysner, M.D. Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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