Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Older than 10 years and younger than 18 years
- Scheduled for idiopathic scoliosis surgery
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
Actively Recruiting
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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