Actively Recruiting
Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment
Led by Poznan University of Medical Sciences · Updated on 2026-05-22
150
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the neurological safety and pain-relieving effects of dexamethasone given either around the nerve (perineurally) or through a vein (intravenously) as an add-on to a brachial plexus nerve block in children having hand or forearm surgery. This clinical trial aims to understand whether perineural dexamethasone causes nerve injury compared to intravenous dexamethasone or placebo. The study will also explore long-term safety, which has limited evidence especially for children. All participants will receive a single brachial plexus block with ropivacaine guided by ultrasound. They will be randomly assigned to one of three groups: perineural dexamethasone, intravenous dexamethasone, or placebo (normal saline) given both ways. The doses are weight-based with maximum limits. The trial is double-blind, meaning neither participants nor researchers know the group assignments. Treatment effects will be compared over a 12-month period. During the study, neurological function will be assessed through clinical exams and blood tests measuring serum neurofilament light chain, a marker for nerve damage. Researchers will also evaluate pain levels using standard scales, opioid use after surgery, and any adverse events. Follow-up will continue for 12 months to monitor nerve safety and recovery outcomes. This may help establish safe dosing and administration guidelines for dexamethasone in pediatric nerve blocks.
CONDITIONS
Brief Title
Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 months to 16 years
- Scheduled elective hand or forearm surgery under general anesthesia with a brachial plexus block
- ASA physical status I-III
- Planned use of ultrasound-guided regional anesthesia
- Written informed consent from parent(s) or legal guardian and age-appropriate assent from the child
You will not qualify if you...
- Pre-existing neurological disease or peripheral neuropathy
- Preoperative sensory deficit in the operative limb
- Infection at or near the needle insertion site
- Coagulopathy or therapeutic anticoagulation
- Systemic infection or sepsis
- Chronic steroid therapy within 30 days before surgery
- Known allergy to ropivacaine or dexamethasone
- Diabetes mellitus
- BMI greater than 99th percentile for age and sex
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial within 30 days
- Refusal of consent
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 - Single day of surgery
Participants receive a brachial plexus block with ropivacaine combined with either perineural dexamethasone, intravenous dexamethasone, or placebo as part of their pediatric hand or forearm surgery.
1 surgical visit (in-person)
Duration - Up to 30 days after surgery
Participants are monitored for pain, opioid use, neurological integrity, and adverse events after surgery.
Multiple visits during the first 48 hours and additional follow-ups up to 30 days
Duration - Up to 12 months
Participants are followed for neurological safety and functional recovery including biomarker assessments for up to 12 months after surgery.
Periodic visits over 12 months
Trial Site Locations
Total: 1 location
1
Poznan University of Medical Sciences
Poznan, Poland, 62-701
Actively Recruiting
Research Team
M
Malgorzata Reysenr, MD PhD
M
Malgorzata Reysner, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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